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Drug Information Update May 2020

www.performrx.com 200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved

TABLE OF CONTENTS NEWLY AVAILABLE GENERICS ................................................................. 2

NEW DRUG ENTITIES/STRENGTHS/COMBINATIONS ............................... 3

NEW INDICATIONS (EXISTING DRUGS) .................................................... 5

FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS .............................. 7

STUDIES AND RECENT TOPICS ............................................................... 18

RECALLS ................................................................................................ 23

CURRENT DRUG SHORTAGES ................................................................ 38


NEWLY AVAILABLE GENERICS

GENERIC DRUG NAME STRENGTH & DOSAGE FORM

GENERIC MANUFACTURER BRAND NAME

MICAFUNGIN SODIUM

50 MG, 100 MG IV SOLUTION FOR

RECONSTITUTION (VIAL)

FRESENIUS KABI MYCAMINE

DEFERASIROX

180 MG TABLET TEVA USA JADENU

METHYLPHENIDATE HCL

10 MG, 15 MG, 20 MG, 30 MG, 40 MG, 50 MG,

60 MG ER CAPSULE RHODES PHARMACE APTENSIO XR

TOLVAPTAN 30 MG TABLET ASCEND LABORATO SAMSCA


NEW DRUG ENTITIES/STRENGTHS/COMBINATIONS

DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES

PRENATAL VITAMINS WITH

LOW OR NO IRON AZESCHEW

PNV NO.165/ IRON FUM/ FOLIC ACID

13 MG-1 MG CHEWABLE

TABLET NEW COMBINATION

ANTINEOPLASTICS ANTIBODY/ANTIBO

DY-DRUG COMPLEXES

TRODELVY SACITUZUMAB GOVITECAN-HZIY

180 MG IV SOLUTION FOR

RECONSTITUTION (VIAL)

NEW ENTITY

ANTINEOPLASTIC SYSTEMIC ENZYME

INHIBITORS TUKYSA TUCATINIB 50 MG, 150 MG

TABLET NEW ENTITY


INHIBITORS PEMAZYRE PEMIGATINIB 4.5 MG, 9 MG,

13.5 MG TABLET NEW ENTITY

ANTIBIOTIC ANTINEOPLASTICS JELMYTO MITOMYCIN 40 MG URETHRAL

KIT NEW STRENGTH

SEDATIVE HYPNOTICS, NON-

BARBITURATE DAYVIGO LEMBOREXANT 5 MG, 10 MG

TABLET NEW ENTITY

CALCIUM CHANNEL BLOCKERS NYMALIZE NIMODIPINE

30 MG/5 ML, 60 MG/10 ML ORAL

SYRINGE

NEW STRENGTH, NEW DOSAGE FORM

ANTINEOPLASTIC – ANTI-CD38

MONOCLONAL ANTIBODY

DARZALEX FASPRO

DARATUMUMAB/HYALURONIDASE-

FIHJ

1,800 MG-30,000 UNITS/

15 ML SUB-Q SOLUTION (VIAL)

NEW ENTITY

LHRH(GNRH) AGONIST FENSOLVI LEUPROLIDE

ACETATE

45 MG (PEDIATRIC 6-MONTH) SUB-Q SUSPENSION FOR RECONSTITUTION

(SYRINGE)

NEW STRENGTH

TOPICAL ANTI-INFLAMMATORY

STEROIDAL HALOG HALCINONIDE 0.1% TOPICAL

SOLUTION REINTRODUCED BRAND


DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES MIOTICS AND

OTHER INTRAOCULAR

PRESSURE REDUCERS

DURYSTA BIMATOPROST 10 MCG

INTRAOCULAR IMPLANT

NEW ROUTE, DOSAGE FORM, AND STRENGTH

TOPICAL PREPARATIONS, ANTIBACTERIALS

BASADROX SILVER TOPICAL GEL PACKET MEDICAL DEVICE


INHIBITORS TABRECTA CAPMATINIB

HYDROCHLORIDE 150 MG, 200 MG

TABLET NEW ENTITY


INHIBITORS RETEVMO SELPERCATINIB 40 MG, 80 MG

CAPSULE NEW ENTITY

ANTIVIRAL NUCLEOTIDE

ANALOGS REMDESIVIR* REMDESIVIR* 100 MG/20 ML IV

SOLUTION VIAL NEW ENTITY

OPIOID ANALGESICS DILAUDID HYDROMOR-

PHONE HCL/PF

0.2 MG/ML INJECTABLE

SYRINGE NEW STRENGTH

ANTIPARKIN-SONISM DRUGS,

OTHER OSMOLEX ER AMANTDINE HCL

322 MG/DAY (129 MG X 1, 193 MG X 1) ER TABLET

NEW DOSAGE PACK COMBINATION

TOPICAL ANTI-INFLAMMATORY,

NSAIDS LICART DICLOFENAC

EPOLAMINE

1.3% TRANSDERMAL

PATCH NEW DOSAGE FORM

ARGININE VASOPRESSIN

(AVP) RECEPTOR ANTAGONISTS

JYNARQUE TOLVAPTAN

15 MG (AM) /15 MG (PM), 30 MG

(AM) /15 MG (PM) TABLETS

NEW DOSAGE PACK COMBINATION


INHIBITORS QINLOCK RIPRETINIB 50 MG TABLET NEW ENTITY

*Investigational


NEW INDICATIONS (EXISTING DRUGS)

IMBRUVICA

April 21, 2020

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who are new to therapy. The approval is based on positive results from the landmark Phase 3 E1912 study that was designed and conducted by the ECOGACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by the National Cancer Institute, part of the National Institutes of Health. Today’s milestone marks the 11th U.S. FDA approval for IMBRUVICA® across six disease areas and is the sixth approval for IMBRUVICA® in CLL. Source: The Janssen Pharmaceutical Companies of Johnson & Johnson KEYTRUDA

April 28, 2020

Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an additional recommended dosage of 400 mg every six weeks (Q6W) for KEYTRUDA, Merck’s anti-PD-1 therapy, across all adult indications, including monotherapy and combination therapy. This indication is approved under accelerated approval based on pharmacokinetic data, the relationship of exposure to efficacy and the relationship of exposure to safety. Continued approval for this dosing may be contingent upon verification and description of clinical benefit in the confirmatory trials. This new dosage option will be available in addition to the current dose of 200 mg every three weeks (Q3W). Source: Merck ZEJULA

April 29, 2020

Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK, said: “Women with advanced ovarian cancer have a five-year survival rate of less than 50%. This expanded indication means that many more women with this devastating disease can receive earlier treatment with Zejula, which can extend the time it takes for their cancer to progress.” Source: GlaxoSmithKline FARXIGA

May 6, 2020

AstraZeneca’s FARXIGA® (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular (CV) death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without type 2 diabetes (T2D). The approval by the Food and Drug Administration (FDA) was based on positive results from the landmark Phase III DAPA-HF trial, which showed FARXIGA achieving a statistically significant and clinically meaningful reduction of CV death or hospitalization for heart failure, compared to placebo. The decision follows the Priority Review


designation granted by the FDA earlier this year and the Fast Track designation granted in September 2019. Source: AstraZeneca LYNPARZA®

May 11, 2020

AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (Merck: known as MSD outside the US and Canada) today announced LYNPARZA® (olaparib) in combination with bevacizumab has been approved in the US for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Patients will be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. Source: AstraZeneca and Merck & Co., Inc.


FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS

Dr. Reddy’s Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Nizatidine Oral Solution, 15 mg/mL, Due to Potential Levels of N-nitrosodimethylamine (NDMA) Impurity Amounts above the Levels Established by FDA [posted April 15, 2020] Amneal Pharmaceuticals, LLC, Bridgewater, New Jersey is voluntarily recalling three lots of Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL), packaged in 480 mL bottles to the Consumer Level. Nizatidine Oral Solution was distributed by Gemini Laboratories, LLC, a wholly owned subsidiary of Amneal Pharmaceuticals. The three recalled lots are identified in the table below. Nizatidine Oral Solution is being recalled due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding the levels established by the FDA. Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. Amneal Pharmaceuticals, LLC has not received any reports of adverse events that have been confirmed to be directly related to this recall. Nizatidine Oral Solution manufactured by Amneal, is a prescription oral product used for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD). The Nizatidine Oral Solution lots subject to the recall can be identified by the NDC number and lot number listed on the product label:

NDC Description Lot Expiration Date

60846-301-15 Nizatidine Oral Solution 06598004A 04/2020



The affected Nizatidine Oral Solution lots were distributed directly to wholesalers who further distributed to retail pharmacies and consumers nationwide in the USA. Amneal is notifying its direct customers by mailing (FED Ex Standard Overnight) a recall notification letter and is arranging for return of all recalled product. Anyone with an existing inventory of the product should quarantine the recalled lots immediately. Customers who purchased the impacted product directly from Amneal can call Inmar at (855) 319-4807, Monday – Friday, 8:00 am – 6:00 pm, EST, or e-mail at [email protected] for further information. Consumers should contact their physician or other healthcare provider if they have experienced any problems that may be related to taking or using this drug product.


Consumers who have Nizatidine Oral Solution which is being recalled should stop using the product and can call Inmar at 855-319-4807, Monday – Friday, 8:00 am – 5:00 pm, EST for further information. Consumers who would like to report adverse reactions or quality problems experienced with the use of this product can contact Amneal Drug Safety by phone at 1-877-835-5472, Monday thru Friday, 8:00 am – 6:00 pm, EST, or e-mail at [email protected]. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. ● Complete and submit the report Online ● Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then

complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. Source: U.S. Food and Drug Administration (FDA)

Avet Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Tetracycline HCl Capsules USP, 250 mg and 500 mg Due to Failed Dissolution Specifications [posted April 16, 2020] Avet Pharmaceuticals Inc. (“Avet”), based in East Brunswick, New Jersey, is initiating a voluntary recall of the following lots of Tetracycline HCl Capsules USP, 250 mg and 500 mg, 100-count bottles listed in the table below to the consumer/user level.

Product NDC Lot No Expiry Date

Tetracycline HCL Capsules 250 mg 100 count

23155-017-01 H190666 JUL 2022


23155-018-01 G190609 JUN 2022


23155-018-01 G190610 JUN 2022


23155-018-01 G190611 JUN 2022


23155-018-01 L191027 NOV 2022

Tetracycline HCL Capsules 23155-018-01 L191028 NOV 2022


500 mg 100 count


23155-018-01 K190953 OCT 2022


23155-018-01 K190952 OCT 2022

These drug products are manufactured by Avet Pharmaceuticals Labs Inc. and distributed under the Heritage Pharmaceuticals Inc. label. The voluntary recall is being initiated due to low out of specification dissolution test results. Low dissolution results in less tetracycline available in the body to fight infection. This can lead to treatment failures. For patients with compromised immune systems and the elderly, who may be taking tetracycline to treat a serious infection such as pneumonia, there is a reasonable probability that if there is not enough tetracycline in the body to fight the infection, this could result in rapid progression of the infection and death. To date, Avet has not received adverse event reports or complaints related to this event. Tetracycline HCl Capsules USP, 250 mg and 500 mg are indicated in the treatment of infections caused by susceptible strains of the designated organisms, including upper and lower respiratory infections, skin and soft tissues infections, infections caused by Rickettsiae, as adjunctive therapy in severe acne. The recalled Tetracycline HCl Capsules 250 mg and 500 mg lots were distributed to wholesalers and distributors Nationwide in United States between August 2019 and March 2020. Avet is notifying its distributors and customers by a separate notification to distributors and through Qualanex and is arranging for the return of all recalled products. Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking this drug product. Pharmacies and healthcare facilities that have the drug product subject to this recall should immediately stop dispensing this drug product. Consumers with questions regarding this recall should contact Qualanex at 1-888-424-4341. Monday – Friday, 8:00 am – 5:00 pm, EST and or [email protected]. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. ● Adverse reactions or quality problems experienced with the use of this product may be reported to

the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. ● Complete and submit the report Online ● Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then

complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Source: U.S. Food and Drug Administration (FDA)


Fresenius Kabi Issues Voluntary Nationwide Recall of 13 Lots of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter in Reserve Samples

[posted April 20, 2020]

Fresenius Kabi USA, LLC is voluntarily recalling 13 lots of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial and Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter composed of the following elements: carbon, silicon, oxygen and polyamides. Particulate matter was found in eight reserve sample vials.

Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences.

Ketorolac Tromethamine, a nonsteroidal anti-inflammatory drug, is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. The total combined duration of use of oral Ketorolac Tromethamine and Ketorolac Tromethamine injection should not exceed 5 days.

Listed below is a table of the recalled lots distributed nationwide to wholesalers, distributors, hospitals, and pharmacies between May 5, 2018 and December 16, 2019, as well as a copy of the label:

Product Name/ Product size

NDC Product Code

Batch Number

Expiration Date

First Ship Date

Last Ship Date

Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial

63323-162-01 160201 6118737 04/2020 05/30/2018 06/27/2018

6118902 04/2020 08/01/2018 08/15/2018

6119052 05/2020 06/25/2018 07/25/2018

6119752 08/2020 09/28/2018 12/06/2018

6122349 07/2021 09/16/2019 11/04/2019

6122538 09/2021 11/01/2019 12/16/2019

Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL fill in a 2 mL amber vial

63323-162-02 160202 6119229 06/2020 08/09/2018 10/30/2018

6119273 06/2020 09/26/2018 03/30/2019

6119843 09/2020 11/11/2019 01/07/2020

6121115 02/2021 03/30/2019 04/22/2019

6121451 03/2021 04/29/2019 08/05/2019

6121452 03/2021 07/12/2019 10/22/2019

6121496 03/2021 06/21/2019 12/10/2019


Fresenius Kabi is notifying its distributors and customers by letter and asking customers and distributors to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product. Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing any affected lots, and to return the product to Fresenius Kabi. The recall letter and response form are available at https://www.fresenius-kabi.com/us/pharmaceutical-product-updatesExternal Link Disclaimer.

Customers with questions regarding this recall may contact Fresenius Kabi at 1-866-716-2459 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Time. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

● Complete and submit the report Online ● Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then

complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. ● Or, contact Fresenius Kabi at 1-800-551-7176, Monday through Friday, during the hours of 8:00 a.m.

to 5:00 p.m. or via email at: [email protected] or [email protected]


B. Braun Medical Inc. Issues Voluntary Nationwide Recall of One (1) Lot of Ceftazidime for Injection USP and Dextrose Injection USP (50 mL), Duplex Container Due to Out-of-Specification Results for High Molecular Weight Polymers [posted April 20, 2020] Braun Medical Inc. (B. Braun) is voluntarily recalling one (1) lot of 2g Ceftazidime for Injection USP (2g) and Dextrose for Injection USP (50 ml) in Duplex® Container to the hospital/user level. During stability testing of Batch H8J812, test results were found to exceed the specification limits for High Molecular Weight Polymers (HMWP) at the nineteen (19) month [82 week] stability interval. Elevated levels of High Molecular Weight Polymers have been shown to cause kidney damage and liver issues in animal studies. While the impact of HMWP in humans is unknown, B. Braun is initiating this voluntary recall out of an abundance of caution to prevent any risks of adverse reactions due to the elevated HMWP levels. To date there have been no complaints or reports of adverse reactions associated with this product lot. Ceftazidime for Injection USP and Dextrose Injection USP is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible isolates of the designated microorganisms: Lower respiratory tract infections; skin and skin-structure infections; bacterial septicemia; bone and


joint infections; gynecologic infections; intra-abdominal infections; and central nervous system infections. Ceftazidime for Injection USP and Dextrose Injection USP in the DUPLEX® Container is a flexible dual chamber container containing approximately 50 mL of 5% Dextrose Injection in the diluent chamber and ceftazidime in the drug powder chamber. After reconstitution, the concentration is equivalent to 2 g ceftazidime. Ceftazidime for Injection USP and Dextrose Injection USP is packaged in 24 DUPLEX® Containers per case. The affected recalled product includes the following lot number and expiration date:

NDC Ref Dose/Volume Impacted Batch Expiration Date

0264-3145-11 3145-11 2 g per 50 mL H8J812 31 Jul 2020

Product was distributed Nationwide within the United States to domestic distributors. Pictures of the product and product labeling follow this press release. B. Braun is notifying its distributors and customers by an official recall notice sent via certified registered mail and is arranging for return of all recalled products. Facilities and distributors that have product which is being recalled should discontinue use immediately and contact the B. Braun Medical Inc. Customer Support Department at 800-227-2862 Monday through Friday, 8 a.m. – 6 p.m. EST to arrange for product return. Facilities with questions regarding this recall can contact B. Braun by phone at 800-227-2862 Monday through Friday, 8 a.m. – 6 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. ● Complete and submit the report Online ● Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then

complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. Source: U.S. Food and Drug Administration (FDA) Trividia Health, Inc. Issues Nationwide Voluntary Recall for an Isolated TRUE METRIX AIR Blood Glucose Meter with Serial Number TA1548753 [posted April 20, 2020] Trividia Health, Inc. today announced it is initiating a nationwide voluntary recall of one (1) TRUE METRIX® AIR Blood Glucose Meter distributed in the United States to one customer (AssuraMed). The meter was not packaged into store brand or retail branded packaging.


The company has determined that one (1) isolated TRUE METRIX AIR Blood Glucose Meter was packaged into a TRUE METRIX Blood Glucose Meter kit and has an incorrect factory-set unit of measure; the meter displays glucose results in mmol/L rather than mg/dL. If a consumer does not notice the incorrect unit of measure, it is possible that the meter glucose result will be read as a lower blood glucose result than expected, and this may result in the patient’s glucose level remaining high, which can lead to serious injury or impairment with risk of death. There is one (1) affected TRUE METRIX AIR meter with serial number TA1548753 that was packaged into a TRUE METRIX Blood Glucose Meter Kit with the Lot number KW0135 and with UDI # (01)00021292006075(17)200831(10)KW0135(21)TA1548753. It has been determined that this kit was distributed nationwide in the United States in February 2019. Trividia Health has not received any reports of patient injury or an adverse event related to this voluntary recall. Consumers who have or may have the TRUE METRIX AIR meter should do the following: • Check to confirm if you have the affected TRUE METRIX AIR meter by obtaining the meter serial

number (TA1548753) from the serial number label located on the back of the meter, and then visit www.TrividiaHealth.com/air-product-noticeExternal Link Disclaimer or call Trividia Health toll-free at 1-800-518-5726, Monday-Friday, 8AM-8PM EST.

• If you have the affected TRUE METRIX AIR meter, please stop using the meter and call Trividia Health immediately to verify the serial number, and to expedite return and replacement of the affected TRUE METRIX AIR meter at no charge.

• Consumers may continue to test blood glucose using any other Trividia Health blood glucose meter not included in this voluntary recall while waiting for their replacement meter to arrive. Use only the test strips that are intended for use with your blood glucose meter.

Notifications will be sent to US pharmacies, durable medical equipment providers and distributors who may have received this device from Trividia’s customer. Patient safety is a top priority at Trividia Health. The company has notified the U.S. Food and Drug Administration (FDA) of this voluntary product recall and is working with the customer who received the affected meter to quickly resolve this matter. Users within the USA may report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online or by phone. • Complete and submit the report Online • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then

complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. Source: U.S. Food and Drug Administration (FDA) Hydroxychloroquine or Chloroquine for COVID-19: Drug Safety Communication - FDA Cautions Against Use Outside of the Hospital Setting or a Clinical Trial Due to Risk of Heart Rhythm Problems [posted April 24, 2020]


ISSUE: FDA is concerned that hydroxychloroquine and chloroquine are being used inappropriately to treat non-hospitalized patients for coronavirus disease (COVID-19) or to prevent that disease. We authorized their temporary use only in hospitalized patients with COVID-19 when clinical trials are not available, or participation is not feasible, through an Emergency Use Authorization (EUA). These medicines have a number of side effects, including serious heart rhythm problems that can be life-threatening. We have reviewed case reports in the FDA Adverse Event Reporting System database, the published medical literature, and the American Association of Poison Control Centers National Poison Data System concerning serious heart-related adverse events and death in patients with COVID-19 receiving hydroxychloroquine and chloroquine, either alone or combined with azithromycin or other QT prolonging medicines. These adverse events included QT interval prolongation, ventricular tachycardia and ventricular fibrillation, and in some cases, death. We are continuing to investigate these safety risks in patients with COVID-19 and will communicate publicly when more information is available. BACKGROUND: Hydroxychloroquine and chloroquine are FDA-approved to treat or prevent malaria. Hydroxychloroquine is also FDA-approved to treat autoimmune conditions such as chronic discoid lupus erythematosus, systemic lupus erythematosus in adults, and rheumatoid arthritis. Hydroxychloroquine and chloroquine: • Should be used for COVID-19 only when patients can be appropriately monitored in the hospital as

required by the EUA or are enrolled in a clinical trial with appropriate screening and monitoring. FDA is reviewing the safety of their use when used outside of the setting of hospitalized patients for whom use was authorized.

• Have not been shown to be safe and effective for treating or preventing COVID-19. • Are being studied in clinical trials for COVID-19, and FDA authorized their temporary use during the

COVID-19 pandemic under limited circumstances through the EUA, and not through regular FDA approval.

• Being used under the EUA when supplied from the Strategic National Stockpile, the national repository of critical medical supplies to be used during public health emergencies.

• Can cause abnormal heart rhythms such as QT interval prolongation • Can cause dangerously rapid heart rate called ventricular tachycardia. • Pose risks that may increase when these medicines are combined with other medicines known to

prolong the QT interval, including the antibiotic azithromycin, which is also being used in some COVID-19 patients without FDA approval for this condition.

• Should be used with caution in Patients who also have other health issues such as heart and kidney disease, who are likely to be at increased risk of these heart problems when receiving these medicines.

RECOMMENDATION: Patients: • Patients taking hydroxychloroquine or chloroquine for FDA-approved indications to treat malaria or

autoimmune conditions should continue taking their medicine as prescribed.


• The benefits of these medicines outweigh the risks at the recommended doses for these conditions. • Do not stop taking your medicine without first talking to your health care professional and talk to

them if you have any questions or concerns. Be aware that there are no proven treatments for COVID-19 and no vaccine. If you are receiving hydroxychloroquine or chloroquine for COVID-19 and experience irregular heartbeats, dizziness, or fainting, seek medical attention right away by calling 911. Consumers: • Do not buy these medicines from online pharmacies without a prescription from your health care

professional. • Do not take any form of hydroxychloroquine or chloroquine that has not been prescribed for you by

a health care provider. Serious poisoning and death have been reported after mistaken use of a chloroquine product not intended to be taken by humans.

• If you have these medicines in your home, keep them in childproof containers out of the reach of children to prevent accidental poisoning.

Health Professionals: • FDA recommends initial evaluation and monitoring when using hydroxychloroquine or chloroquine

under the EUA or in clinical trials to treat or prevent COVID-19. Monitoring may include baseline ECG, electrolytes, renal function and hepatic tests.

• Be aware that hydroxychloroquine and chloroquine can: o Cause QT prolongation o Increase the risk of QT prolongation in patients with renal insufficiency or failure o Increase insulin levels and insulin action causing increased risk of severe hypoglycemia o Cause hemolysis in patients with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency o Interact with other medicines that cause QT prolongation even after discontinuing the

medicines due to their long half-lives of approximately 30-60 days If a health care professional is considering use of hydroxychloroquine or chloroquine to treat or prevent COVID-19, FDA recommends checking www.clinicaltrials.gov for a suitable clinical trial and considering enrolling the patient. Consider using resources available to assess a patient’s risk of QT prolongation and mortality. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: • Complete and submit the report online. • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the

address on the form or submit by fax to 1-800-FDA-0178. Source: U.S. Food and Drug Administration (FDA)


ICU Medical Issues a Voluntary Nationwide Recall of Lactated Ringer's Injection, USP Due to the Presence of Particulate Matter [posted May 08, 2020] ICU Medical, Inc. is voluntarily recalling one single lot of Lactated Ringer's Injection, USP. The products are being recalled to the hospital/user level due to the presence of particulate matter identified as iron oxide. ICU Medical became aware of this issue through a single customer complaint. Administration of a drug product that contains metal particulate matter could result in adverse events ranging from inflammation at the site of injection to more serious events that could include the formation of a blood clot obstructing the flow of blood which could lead to end-organ damage or death. To date, ICU Medical, Inc. has not received reports of adverse events related to this recall. Lactated Ringer's Injection, USP is indicated for parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient. Product was distributed nationwide both by ICU Medical direct to customers and through medical distributors. The product is for human and veterinary use. The affected product lot, manufactured in the U.S. for ICU Medical by Hospira, a Pfizer company in July 2019 is listed below:

NDC Product Description

Lot Number Expiration Date

Configuration Manufacture Date

Distribution Dates

0409-7953-09 Lactated Ringer’s Injection, USP

07-514-FW 01-Jul-2021 1000 mL Flexible Container

July 2019 September 2019- October 2019

ICU Medical is notifying its distributors and customers of this recall by letter and is arranging for the return of all recalled products. Hospitals/distributors that have product that is being recalled should stop use/further distribution and return to place of purchase. Customers with questions regarding this recall can call ICU Medical at 1-844-654-7780 Monday through Friday between the hours of 8 a.m. and 5 p.m. Central time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. ● Complete and submit the report Online. ● Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then

complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.


● The Center for Veterinary Medicine recommends calling the drug company to report the adverse drug experience or product defect. The drug company responsible for the approved product(s) is required to submit reports of adverse drug experiences and product defects to FDA.

● If you prefer to report directly to the FDA, you can submit FORM FDA 1932a, ● “Veterinary Adverse Experience, Lack of Effectiveness or Product Defect Report”. You can use this

form to report adverse drug experiences for any animal drug (approved or not approved by FDA) or animal device. Unapproved animal drugs include compounded drug products.

● Download the fillable 1932a electronic form and email the completed form to [email protected]

● If you have a question about ADE reporting or need a hard copy of the form, contact CVM by email at [email protected], by phone at 1-888-FDA-VETS (1-888-332-8387)


mailto:[email protected]

mailto:[email protected]


STUDIES AND RECENT TOPICS

Reasons for hope: the drugs, tests and tactics that may conquer coronavirus

April 13, 2020

With much of the world living in lockdown, the spread of the new coronavirus, SARS-CoV-2, that was first detected in China late last year is beginning to slow in some places. As of April 12, 1.8 million had been infected and 115,000 killed by COVID-19, the disease caused by the virus.

Source: reuters.com

FDA offers guidance for generic drug developers of hydroxychloroquine, chloroquine

April 13, 2020

The US Food and Drug Administration (FDA) on Monday issued two new product-specific guidance documents for the unproven but highly demanded potential COVID-19 drugs chloroquine phosphate and hydroxychloroquine sulfate.

The two generic drugs, approved by FDA as malaria drugs, have been touted by President Donald Trump in press conferences during the pandemic, but clinical trial data regarding their efficacy for COVID-19 remain thin.

Source: raps.org

Novo Nordisk's Free Insulin; Delay OK for Thyroid FNA

April 17, 2020

Through its Diabetes Patient Assistance Program, Novo Nordisk is providing complimentary 90-day insulin supplies for patients who lost healthcare coverage due to COVID-19.

A new study is underway to parse out COVID-19 outcomes specifically in people with type 1 diabetes -- trying to differentiate outcomes from those with type 2 diabetes.

Source: medpagetoday.com

Report: Covid-19 patients recovering quickly after getting experimental drug remdesivir

April 17, 2020

Covid-19 patients who are getting an experimental drug called remdesivir have been recovering quickly, with most going home in days, STAT News reported Thursday after it obtained a video of a conversation about the trial.

Source: cnn.com

UK scientists to make a million potential COVID-19 vaccines before proof

April 17, 2020

A million doses of a potential COVID-19 vaccine being developed by British scientists are already being manufactured and will be available by September, even before trials prove whether the shot is effective, the team said on Friday.

Source: reuters.com


Flu Vaccine Safe for Cancer Patients on Pembrolizumab

April 23, 2020

CMS recommends annual influenza vaccinations particularly for patients receiving cancer-directed therapies and those who have an increased risk of complications from influenza. However, immune checkpoint inhibitors (ICIs) are known to lead to immune-related adverse events, presumably due to non-specific activation of the immune system. Even so, some studies show that cancer patients have lower influenza rates and a lower risk of death with vaccination, especially among those over age 65 who received the high-dose influenza vaccine.


An Unsafe Interaction between Pradaxa and Common Meds

April 24, 2020

It was not safe to combine dabigatran (Pradaxa) with P-glycoprotein (P-gp) inhibitors in people with atrial fibrillation (Afib), even when they had normal kidney function, researchers determined from real-world evidence.


Painkillers, sedatives in short supply during COVID-19 pandemic

April 29, 2020

A shortage of painkillers and sedatives for COVID-19 patients struggling to breathe is causing concerned hospital groups to seek changes to increase the supply of these drugs.

Patients with more severe cases of the viral respiratory illness may require ventilators, which are machines that help with breathing. But the process of inserting a plastic tube into a patient’s airway is painful and requires pain medicine and sedation.

Source: rollcall.com

Nearly a dozen approved drugs could be effective against COVID-19: study

April 30, 2020

At least 10 different drug compounds ranging from cancer therapies to antipsychotics and antihistamines may be effective at preventing the new coronavirus from multiplying in the body, according to a multidisciplinary study conducted by a team of scientists in the United States and France.

Source: reuters.com

Experimental coronavirus drug Neumifil shows promise in lab, scientists hope to ‘rapidly’ start clinical trials

April 30, 2020

An antiviral drug which scientists hope could one day be used to prevent and treat COVID-19 has shown promise in lab tests. Its creators envision the medicine taking the form of a nasal spray, and hope to "rapidly" start clinical trials.

Source: newsweek.com


There’s no quality data showing hydroxychloroquine and chloroquine can help Covid-19 patients, scientists say

April 30, 2020

There is no high-quality data showing that taking the anti-malarial drugs hydroxychloroquine and chloroquine can help COVID-19 patients, the authors of a review of existing evidence have warned. As such, they said the drugs should only be used to treat patients taking part in carefully designed clinical trials.

Source: newsweek.com

FDA lifts drug supply chain security requirements for COVID-19 products

April 30, 2020

The US Food and Drug Administration (FDA) on Thursday issued guidance detailing exclusions and exemptions to certain requirements under the Drug Supply Chain Security Act triggered by the coronavirus disease (COVID-19) public health emergency.

FDA says the guidance is meant “to help ensure adequate distribution of finished prescription drug products throughout the supply chain to combat COVID-19.”

Source: raps.org

Anthony Harris, MD, on Curbing Antibiotic-Resistant Infections

May 1, 2020

In the U.S., health care-associated infections remain the most common complication of hospitalization. These infections can lead to morbidity and mortality, and cost the healthcare system close to $10 billion annually.

Antibiotic-resistant Gram-negative bacteria, considered an "urgent" and "serious" threat by the Centers for Disease Control and Prevention, rank high on the list of infection-causing pathogens.


Common Treatment May Not Help Seniors with Underactive Thyroid

May 4, 2020

The medication Synthroid (levothyroxine) is often used to treat a condition called subclinical hypothyroidism, but a new study suggests the treatment might be a waste of time.

For the study, researchers followed 638 people aged 65 and older with subclinical hypothyroidism, also known as mild thyroid failure. About half of the patients were given the medication, and half were given an inactive placebo.

Source: healthday.com

Gilead in talks to expand global supply of COVID-19 drug remdesivir

May 5, 2020

Gilead Sciences Inc (GILD.O) said on Tuesday it was in discussions with chemical and drug manufacturers to produce its experimental COVID-19 drug remdesivir for Europe, Asia and the developing world through at least 2022.


The drugmaker did not disclose details about the companies.

Source: reuters.com

Northwestern develops coronavirus antibody test using single drop of blood

May 6, 2020

Northwestern University researchers have put forth a coronavirus antibody test that they say can be completed using only a single drop of dried blood from a finger prick. The test, which is specifically designed to search for SARS-CoV-2 antibodies IgM and IgG, will help in “evaluating how effective policies such as social distancing or closing schools and restaurants are working to prevent viral transmission,” as well as eliminate the need for a clinical setting, according to the team’s lead author.

Source: foxnews.com

Triple drug therapy helps coronavirus patients recover more quickly, study finds

May 8, 2020

A combination of three antiviral drugs plus an immune system booster seemed to help patients recover more quickly from coronavirus infections, doctors in Hong Kong reported Friday.

They said the approach needs more testing but it could offer another treatment possibility for Covid-19 patients. Currently the only authorized treatment is the experimental antiviral drug remdesivir, which also shortens the duration of illness but is limited in supply.

Source: cnn.com

Does Insulin Resistance Worsen Breast Cancer Prognosis in Black Women?

May 12, 2020

Insulin resistance was one factor that mediated invasive breast cancer prognosis among black women, researchers reported.

In a cross-sectional study of 115 women newly diagnosed with invasive breast cancer, metabolic syndrome was twice as prevalent among black women than white women (40% vs 20%, P<0.0001), according to Emily Gallagher, MD, of the Icahn School of Medicine at Mount Sinai in New York City, and colleagues.


Moderna's potential coronavirus vaccine gains FDA's 'fast track' status

May 12, 2020

Moderna Inc said on Tuesday the U.S. Food and Drug Administration granted “fast track” designation to its experimental coronavirus vaccine, a move that speeds up the regulatory review process.

Moderna has been racing to develop a safe and effective vaccine against the novel coronavirus that has killed more than 285,000 people globally.

Source: reuters.com


IL-17A Blockers Succeed in Spine Disease

May 13, 2020

Inhibition of interleukin (IL)-17 was an effective and safe option for the treatment of ankylosing spondylitis in a meta-analysis of six randomized clinical trials.

The primary endpoint of a 20% improvement on the criteria of the Assessment of Spondyloarthritis International Society (ASAS20) at week 16 was met by 57.6% of patients receiving secukinumab (Cosentyx) or ixekizumab (Taltz) compared with 35.3% of those given placebo, for a risk ratio of 1.63 (95% CI 1.45-1.84, P<0.001), according to Yufeng Yin, MD, of Soochow University in Jiangsu, China, and colleagues.



RECALLS

Product Type Product Description Classification Code Info Reason for Recall Recalling

Firm Drugs Ceftazidime for Injection

USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11

Class I Lot #: H8J812, Exp. Date 31 JUL 2020

Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.

B. Braun Medical Inc

Drugs Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-017-01

Class I Lot # H190666, Exp JUL 2022

Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.

Avet Pharmaceuticals, Inc.

Drugs Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-018-01

Class I Lot #s: G190609, G190610, G190611, Exp Jun 2022: L191027, L191028, Exp Nov 2022: K190953, K190952, Exp Oct 2022

Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.

Avet Pharmaceuticals, Inc.

Drugs Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count bottle (NDC 52959-0003-12), c) 14-count bottle (NDC 52959-0003-14), d) 15-count bottle (NDC 52959-0003-15), e) 16-count bottle (NDC 52959-0003-16), f) 20-count bottle (NDC 52959-0003-20), g) 30-count bottle (NDC 52959-0003-30), h) 60-count bottle (NDC 52959-0003-60), Rx Only, Mfg.

Class II Lot # ATP12ZT, Exp. 05/21

cGMP Deviations H J Harkins Company Inc dba Pharma Pac



Firm Aurobindo; Repack: H.J. Harkins Co., Inc., Grover Beach, CA 93433

Drugs Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01

Class II Lot #: 058180015A, 058180016A, Exp. Date 07/2021; 05818017B1, Exp. Date 09/2021

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Aurobindo Pharma USA Inc.


Class II Lot #: 059180023A, 059180024A and 059180025A, Exp. Date 05/2021




Class II Lot #: 060180017A, 060180019B1, 060180020A and 060180021A, Exp. Date 06/2021



Drugs Betahistine 16 mg Capsule 180 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Class II Lot: 45266 Discard by: 9/26/2020

Lack of Processing Control

The Medicine Shoppe Pharmacy

Drugs Bi-Est (1:1) Progest/Test 0.5 mg/1.5 mg/mL cream 60 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Bi-Est (1:1) Progest/Test 0.5 mg/40 mg/10.5 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Bi-Est (1:1) Progesterone/Testost 1.0 mg/60 mg/0.5 mg/mL



The Medicine



Firm Cream 60 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Shoppe Pharmacy

Drugs Bi-Est (1:1)/Progesterone/Testosterone 2.0 mg/40 mg/1.0 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Bi-Est (1:1)/Progesterone/Testosterone 2.5/150/1.5 mg/mL Versabase CR 90 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Bi-Est (50/50)/Progesterone 1.25 mg/80 mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Class II Lot: 45006 Discard by: 7/18/2020; 45251 Discard by: 9/22/2020



Drugs Bi-Est (50/50)/Progesterone/Testost 1.5/100/0.5 mg Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Bi-Est (50/50)/Progesterone/Testosterone 1.5 mg/40 mg/0.5 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Bi-Est (50/50/Progesterone 0.2 mg/70 mg Cream 30 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Bi-Est (8:2) Progest/Test 2/80/3 mg/mL cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL






Firm Drugs Bi-Est

(8:2)/DHEA/Testosterone 0.8 mg/ 9/0.4 mg/0.2 mg/mL Cream 6 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Bi-Est (8:2)/Progest/Test/DHEA 6/50/0.5/10 mg/mL Cream 30 mL, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Bi-Est (8:2)/Progesterone 2/100 mg/mL capsule 90 caps bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Bi-Est (8:2)/Progesterone/Testosterone 0.5/75 mg per 0.2 mL Cream 6 mL jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Bi-Est 1:1/Progest/DHEA 0.5 mg/180 mg/25 mg/mL Cream 30 mL jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Bi-Est 1:1/Progest/DHEA 1/40/5 mg/mL Cream 30 mL jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Bi-Est 1:1/Progesterone/Testosterone 1mg/40 mg/0.5 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Bi-Est 1:1/Progesterone/Testosterone 2.0/100/0.25 mg/mL Cream 30 gm tube, Rx, The






Firm Medicine Shoppe Pharmacy, Port Charlotte, FL

Drugs Bi-Est 8:2/Progesterone 2.5 mg/150/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Bi-Est 8:2/Progesterone/Testosterone DHEA 4.0/100/1/25.0 mg capsules 90 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Bi-Est8:2/Progesterone/Testosterone 1.0/50 MG/.5MG/ML Cream 30 GM tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Bi-Est8:2/Progesterone/Testosterone 1.0/50 MG/.5MG/ML Cream 30 GM, tube Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01

Class II Lot #: F800779, Expiry 4/2020

Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.

Lupin Pharmaceuticals Inc.

Drugs Clobetasol Mouth Rinse 0.05% Solution 450 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours

Class II Lot: 86647 Exp. 09/2020

Defective Delivery System: Out of specification for

Noven Therapeutics, LLC



Firm (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5552-3

mechanical peel and shear.

Drugs Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5554-3

Class II Lot: 86354 Exp. 08/2020

Defective Delivery System: Out of specification for mechanical peel and shear.


Drugs Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5555-3

Class II Lots: 86355 Exp. 07/2020; 86356 Exp.08/2020; 86550 Exp. 07/2020; 87348 Exp. 01/2021; 87965 Exp. 01/2021

Defective Delivery System: Out of specification for mechanical peel and shear.


Drugs Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 30, package in 1.5 fl. oz. (44 mL) bottles, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 020908422698

Class II Lot #: 22J19, Exp 07/21

Microbial contamination of non-sterile products: positive test for yeast and bacteria.

Filltech USA, LLC

Drugs Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a) 1.5 fl. oz. (44 mL) tottles, UPC: 087052727338; b) 2 Fl. OZ. (59 mL) tubes, UPC: 08705272732; c) 4 FL. OZ. (118 mL) tubes, UPC: 087052727345, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144

Class II Lot #: a) 05J19, Exp 07/21; b) 05J19, Exp 07/21, 43L19, Exp 09/21; c) 43L19 Exp 09/21, 44L19 Exp 09/21

Microbial contamination of non-sterile products: positive test for yeast and bacteria.

Filltech USA, LLC



Firm Drugs Diethylstilbestrol 1 mg

capsule 300 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. NDC 0093-5986-27

Class II Lot # 007F19AA, exp. date 04/2021

CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.

Teva Pharmaceuticals USA

Drugs Ergotamine Tartrate 1 mg/Caffeine 100 mg base F Suppository (Pink) 48 suppositories, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Ergotamine Tartrate 1 mg/Caffeine 100 mg Base Suppository (Pink) 48 count box, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Estradiol 1.8 mg capsule 30 cap bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Estradiol Vag Cream 0.01% Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 800-499-3100

Class II Lot #: 18K26-BB02-PR00553, Reassay 10/09/2023 Product # 700365, 700362 & 700363

cGMP deviations: Presence of foreign material (Teflon) introduced at the production level.

B & B Pharmaceuticals, Inc.



Firm Drugs Estradiol/Progesterone/Test

osterone 1.5/100/1.25 mg/mL Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Estriol 5 mg Suppository 36 each box, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Estriol Vaginal Cream (0.1%) 1 mg Cream 30 GM tubes, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Class II Lot: 45036 Discard by: 7/31/2020; 45075 Discard by:8/7/2020



Drugs Estriol/Testosterone Vaginal 0.1/0.1% Cream 30 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Fluorouracil (5-FU) 4.5% Cream 100 GM, tube Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99

Class II Lot #: 198180048A, Exp. Date 04/2021; 198180061A, Exp. Date 06/2020; 19819017A1, Exp. Date 02/2021



Drugs Hydrocortisone 2.5%/Econazole 1% 50/50 Using Powder 25%/1% Cream 60 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Hydrocortisone in Aquaphor/Therapeutic Moisturizing Cream 100 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL






Firm Drugs Hydromorphone Oral 1

mg/mL Solution 240 mL, bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Hydroquinone/Fluocinolone/Tretonoin/Kojic Acid 4/0.01/0.05/2% Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL) in vial 2, Rx Only, Distributed by: Baxter Healthcare Corporation Clintec Nutrition Division Deerfield, IL 60015 USA, NDC 54643-5647-0

Class II Lot #: JX907, Exp. Date 02/2021

Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins

Sandoz, Inc

Drugs Ketoprofen/DMSO 20%/10% Lipoderm 50 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, NDC 65862-247-08

Class II Lot #: 24719001A1, Exp. Date 03/2021



Drugs Levothyroxine (T4)/Liothyronine (T3) SR 130 mg/175 mg capsule 21 capsules bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured by: Lupin Limited Pithampur (M.P.)

Class II Lot # Q000255, Exp 01/2022

Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of

Lupin Pharmaceuticals Inc.



Firm 454 775, India. NDC 68180-0981-03

20 mg/1000 count bottles.

Drugs Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct. (60429-316-10) bottles, GSMS Incorporated, Manufactured by Arrow Pharm (Malta) Ltd., Packaged by GSMS Incorporated, Camarillo, CA 93012, USA

Class II Lot Code: GS018406, Exp. Date 6/30/2020; GS018858, Exp. Date 7/31/2020; GS019108, Exp. Date 7/31/2020; GS018521, Exp. Date 7/31/2020; GS018605, Exp. Date 7/31/2020; GS018911, Exp. Date 7/31/2020

CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products.

Golden State Medical Supply Inc.

Drugs Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34

Class II Lot #: 031180028A, Exp. Date 03/2021



Drugs Naltrexone (Loxoral) 4.5 mg Capsules, 60 count bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Naltrexone 4.5 mg/mL Suspension 30 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15

Class II 06598004A 04/2020 06599001A 12/2020 06599002A 12/2020

CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.

Amneal Pharmaceuticals of New York, LLC

Drugs Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-046-01






Firm Drugs Paregoric Alternate Elixir

300 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Paregoric Compound (contains Morphine) Solution 480 mL bottle, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube, labeled as a) Bimark Inc., bimark.com; b) NOCO TRAIL REPORT, www.NoCoTrailReport.org; c) Herbruck's, d) St. Mark's Outpatient Surgery Center, 1250 East 3900 South Suite 100, Salt Lake City, UT 84124, e) Trust Company Oklahoma, trustok.com, f) Creekside Dental, www.creeksidedentalkennewick.com, g) Children's Healthcare of Atlanta Hughes Spalding, h) Great Smiles Orthodontics, Dr. Savage & Dr. Weissman, Crestline. Inverness.Turssville, www.bracebygreatsmiles.com, i) Acceleration station, j) The Children's Therapy & Learning Center, www.childrenstlc.com. FLAVORED LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube labeled as a) Gregory P. Miller DDS FAGD, 1140 South Avenue North Mankato, MN 56003,

Class II Lot #: 14381, Exp. Date 9/2023

Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.

Yusef Manufacturing Laboratories, LLC

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Firm www.gregmillerdds.com, b) Shelby, c) Carolina Custom Traders, Wake Forest, North Carolina, c) Palm Springs Dental Associates Jonathan W. Preble, DMD, 499 E. Central Parkway, Suite 200, Altamonte Springs, FL 32701, www.drjpreble.com. LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube labeled as Family Dental of Thronton, 12889 Quebec St, Thornton, CO 80602, www.FamilyDentalofThornton.com.

Drugs Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-105-01




Drugs Progesterone 200 mg Capsules 90 capsules, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Class II Lot: 45106 Discard by: 8/16/2020; 45128 Discard by: 8/25/2020; 45227 Discard by: 9/14/2020



Drugs Progesterone/Natacream 20 mg/2% mL Cream 60 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Progesterone/Versa Base 20 mg (2%) Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc.

Class II Lot #: 05319004A1, Exp. Date 03/2022

CGMP Deviations: Products were manufactured in a processing area in


http://bimark.com/

http://bimark.com/

http://bimark.com/

http://bimark.com/

http://bimark.com/

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http://bimark.com/

http://bimark.com/

http://bimark.com/

http://bimark.com/

http://bimark.com/

http://bimark.com/

http://bimark.com/

http://bimark.com/

http://bimark.com/

http://bimark.com/

http://bimark.com/

http://bimark.com/



Firm Dayton, NJ 08810, NDC 65862-053-90

which water leakage was observed

Drugs Testosterone in Atrevis 50 mg/mL Gel 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Testosterone in Atrevis 75 mg/mL Gel 90 GMS tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Testosterone w/ Atrevis 100 mg/mL GEL, 90 gm pump, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Testosterone w/ Atrevis 20 mg (2%) Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Testosterone W/Cosmetic HRT Base 100 MG (10%) Cream 30 GM, tubes Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs Testosterone w/Cosmetic HRT Base 20 mg (2%) Cream 30 GM jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL

Class II Unknown Lack of Processing Control


Drugs Tretinoin 0.1% in Versabase Cream 0.1% Versabase CR 45 gm jar, Rx, The Medicine Shoppe Pharmacy, Port Charlotte, FL




Drugs ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA, NDC 0573-0871-08

Class III Lot #: 9344AA, 9345AA

Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card

Glaxosmithkline Consumer Healthcare Holdings



Firm Drugs ChapStick Total Hydration

Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA NDC 0573-0873-08

Class III Lot #: 9343AA, 9343BA



Drugs ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA NDC 0573-0872-08

Class III Lot #: 9346AA, 9347AA



Biologics

Cholera Vaccine Live Oral Class III 7000014; Vaxchora, not meeting product specifications, was distributed.

PaxVax, Inc.

Drugs Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA, NDC 43598-510-10

Class III Lot #: C900642, Exp. 06/2020

Discoloration: product contains brown pellets

Dr. Reddy's Laboratories, Inc.

Drugs Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02

Class III Lot 081887A, EXP 08/2021

Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.

Akorn Inc

Drugs Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only,

Class III Lot #: M02199D, M02246D, Exp 5/2020

Failed dissolution specifications: Low stage 3 results obtained

The Harvard Drug Group



Firm Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61

for dissolution during routine stability testing.

*Please refer to FDA website for further information at: http://www.fda.gov/Safety/Recalls/default.htm


CURRENT DRUG SHORTAGES

Thiamine Injection April 20, 2020 Reason for the Shortage

● Fresenius Kabi has thiamine injection available. ● Mylan Institutional did not provide a reason for the shortage.

Estimated Resupply Dates ● Fresenius Kabi has short-dated thiamine 100 mg/mL 2 mL vials available with an expiration date

of <3months. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=502 Sterile Water for Injection – Small Volume Vials April 20, 2020 Reason for the Shortage

• American Regent has sterile water for injection available. • Fresenius Kabi had sterile water on shortage due to increased demand. • Hikma has sterile water for injection available. • Pfizer had sterile water for injection in vials on shortage due to increased demand.

Estimated Resupply Dates • American Regent has sterile water for injection 10 mL and 20 mL vials available with short

expiration dating. • Fresenius Kabi has sterile water for injection 5 mL vials on back order and the company cannot

estimate a release date. • Hikma has short-dated sterile water for injection 10 mL vials in 25 count available with an

expiration date of May 2020. • Pfizer has sterile water for injection 100 mL vials available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=375 Meropenem Injection April 20, 2020 Reason for the Shortage

• AuroMedics did not provide a reason for the shortage. • Pfizer has meropenem injection on shortage due to manufacturing delays. Meropenem 500 mg

and 1 gram vials in 25 count were discontinued in February 2020. • Sagent discontinued meropenem injection. • Sandoz did not provide a reason for the shortage. • WG Critical Care launched meropenem in April 2020.

Estimated Resupply Dates • AuroMedics has meropenem 500 mg and 1 gram vials on intermittent back order and the

company is releasing supplies as they become available. • Pfizer has Merrem 500 mg and 1 gram vials on back order and the company estimates a release

date of February 2023. The meropenem 500 mg and 1 gram vials in 25 count are on back order and the company estimates a release date of February 2023.

• Sandoz has all meropenem presentations on back order and the company cannot estimate a release date.


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=475 Immune Globulin, Intravenous or Subcutaneous (Human) April 20, 2020 Reason for the Shortage

• ADMA Biologics has Bivigam on allocation through BioCare SD. • CSL Behring has Hizentra and Privigen on shortage due to increased demand. • Grifols has Gamunex-C and Flebogamma on shortage due to increased demand. • Kedrion Biopharma has Gammaked available to current customers. • Octapharma has Octagam available. • Takeda has HyQvia, Cuvitru, and Gammagard on shortage due to increased demand.

Estimated Resupply Dates • ADMA Biologics has Asceniv 10% liquid and Bivigam 10% on allocation through a distribution

partner. • CSL Behring is releasing Hizentra and Privigen regularly and distributors are allocating product. • Grifols is releasing Gamunex-C and Flebogamma regularly and distributors are allocating

product. • Grifols has Xembify 20% solution on allocation through distributors. • Kedrion has Gammaked on allocation to its current customers. • Takeda has Cuvitru and HyQvia on allocation and the company is reviewing all orders. • Takeda is reviewing all Gammagard Liquid orders and the company is allocating product as it

becomes available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=527 Bivalrudin Injection April 20, 2020 Reason for the Shortage

• Accord has temporarily discontinued bivalirudin. • Apotex has discontinued bivalirudin. • AuroMedics did not provide a reason for the shortage. • Baxter has 250 mg/50 mL bivalirudin premixed bags available. The company is not actively

producing the 500 mg/100 mL bags due to low demand. • Dr. Reddy's has bivalirudin available. • Fresenius Kabi has bivalirudin available. • Pfizer has bivalirudin available. • Sandoz has bivalirudin available.

Estimated Resupply Dates

• AuroMedics has bivalirudin 250 mg vials on intermittent back order and the company is releasing supplies as they become available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=569


Amobarbital Sodium Injection April 20, 2020 Reason for the Shortage

• Bausch Health did not provide a reason for the shortage. They are the sole suppliers of amobarbital injection.

Estimated Resupply Dates • Bausch Health has Amytal 500 mg vials on back order and the company estimates a release date

of late-August to early-September 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=604 Alprostadil Urethral Suppositories April 20, 2020 Reason for the Shortage

• Mylan did not provide a reason for the shortage. Estimated Resupply Dates

• Mylan has Muse 125 mcg, 250 mcg, 500 mcg, and 1,000 mcg suppositories on back order and the company estimates a release date of late-July 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=605 25% Dextrose Injection April 20, 2020 Reason for the Shortage

• Pfizer has 25% dextrose on shortage due to manufacturing delays. Estimated Resupply Dates

• Pfizer has 25% dextrose 10 mL Ansyr syringes available in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=483 Levetiracetam Injection April 21, 2020 Reason for the Shortage

• American Regent did not provide a reason for the shortage. • Athenex did not provide a reason for the shortage. • AuroMedics did not provide a reason for the shortage. • Dr. Reddy's has levetiracetam injection available. • Fresenius Kabi has levetiracetam injection available. • Hikma did not provide a reason for the shortage. • Mylan has levetiracetam injection available. • Pfizer has levetiracetam injection on shortage due to manufacturing delays. • Sagent did not provide a reason for the shortage. • Sun Pharma are not manufacturing levetiracetam injection at this time. • UCB has product available. • X-Gen did not provide a reason for the shortage.

Estimated Resupply Dates • AuroMedics has levetiracetam 5 mg/mL 100 mL and 10 mg/mL 100 mL premixed bags on

intermittent back order and the company is releasing product as it becomes available.


• Hikma has levetiracetam 100 mg/mL 5 mL vials on back order and the company estimates a release date of early-May 2020.

• Pfizer has levetiracetam 100 mg/mL 5 mL vials available in limited supply. • Sagent has levetiracetam 100 mg/mL 5 mL vials on back order and the company estimates a

release date of January 2021. • X-Gen has levetiracetam 100 mg/mL 5 mL vials on back order and the company estimates a

release date of early-July 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=84 Diphenhydramine Injection April 21, 2020 Reason for the Shortage

• Armas Pharmaceuticals has diphenhydramine injection available.[1] • Fresenius Kabi has diphenhydramine injection available.[2] • Hikma has diphenhydramine injection available.[3] • Mylan has diphenhydramine injection available.[4] • Pfizer has diphenhydramine injection on shortage due to manufacturing delays.[5]

Estimated Resupply Dates • Hikma has diphenhydramine 50 mg/mL 1 mL vials on allocation.[3] • Pfizer has diphenhydramine 50 mg/mL 1 mL vials on back order and the company estimates a

release date of January 2021.[5] https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=456 Benztropine Mesylate Injection April 21, 2020 Reason for the Shortage

• Akorn is not marketing benztropine 1 mg/mL 2 mL ampules and Cogentin 1 mg/mL 2 mL ampules.

• Fresenius Kabi did not provide a reason for the shortage. • Hikma did not provide a reason for the shortage.

Estimated Resupply Dates • Fresenius Kabi has short-dated benztropine 1 mg/mL 2 mL vials available with an expiration date

of <7 months. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=497 Tramadol Tablets April 22, 2020 Reason for the Shortage

• Amneal has tramadol tablets available. • Major has tramadol tablets available. • Mylan has tramadol tablets available. • Sun Pharma has tramadol tablets available. • Virtus did not provide a reason for the shortage. • Zydus has tramadol tablets available.

Estimated Resupply Dates • Virtus has tramadol 50 mg tablets in 100 and 500 count bottles on allocation.


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=628 Testosterone Pellets for Subcutaneous Implantation April 22, 2020 Reason for the Shortage

• Endo Pharmaceuticals did not provide a reason for the shortage. Estimated Resupply Dates

• Endo Pharmaceuticals has Testopel pellets for subcutaneous implantation on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=643 Telmisartan Tablets April 22, 2020 Reason for the Shortage

• Alembic has telmisartan available. • Amneal Pharmaceuticals discontinued telmisartan tablets. • Aurobindo refuses to provide information. • Cadista discontinued telmisartan tablets. • Camber Pharmaceuticals discontinued telmisartan tablets. • Glenmark Pharmaceuticals did not provide a reason for the shortage. • Hikma is not marketing telmisartan tablets. • Mylan has telmisartan available. • Sandoz discontinued telmisartan tablets. • Solco Healthcare did not provide a reason for the shortage. • Torrent discontinued telmisartan tablets. • Zydus did not provide a reason for the shortage.

Estimated Resupply Dates • Boehringer Ingelheim has Micardis 40 mg tablets on back order and the company cannot

estimate a release date. • Glenmark Pharmaceuticals has telmisartan 20 mg and 80 mg tablets on back order and the

company cannot estimate a release date. • Solco has all preparations of telmisartan tablets on back order and the company cannot

estimate a release date • Zydus has all telmisartan tablet presentations on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=606 Levetiracetam Immediate-Release Tablets April 22, 2020 Reason for the Shortage

• Accord discontinued levetiracetam immediate-release tablets. • Aurobindo refuses to provide availability information. • Camber did not provide a reason for the shortage. • Lupin did not provide a reason for the shortage. • Major has levetiracetam immediate-release tablets available. • Mylan did not provide a reason for the shortage. • OWP did not provide a reason for the Roweepra shortage.


• Torrent did not provide a reason for the shortage. • UCB has Keppra immediate-release tablets available.

Estimated Resupply Dates • Lupin has levetiracetam 500 mg immediate-release tablets in 500 count on back order and the

company cannot estimate a release date. The 1,000 mg immediate-release tablets in 60 and 500 count are on back order and the company cannot estimate a release date.

• Mylan has levetiracetam 250 mg immediate-release tablets in 120 and 500 count bottles and 750 mg immediate-release tablets in 500 count bottles on back order and the company estimates release dates in late-June 2020. The 500 mg immediate-release tablets in 120 and 500 count bottles are on back order and the company estimates a release date of late-May 2020 for the 120 count and mid-May 2020 for the 500 count.

• OWP has Roweepra immediate-release tablets on back order and the company cannot estimate a release date.

• Torrent has levetiracetam 250 mg, 500 mg, and 750 mg immediate-release tablets in 250 and 500 count on back order and the company cannot estimate a release date. The 1,000 mg immediate-release tablets in 120 and 500 count are also on back order and the company cannot estimate a release date.

• UCB has levetiracetam 750 mg immediate-release tablets in 120 count and 1,000 mg immediate-release tablets in 60 count on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=533 Amyl Nitrite Inhalation April 22, 2020 Reason for the Shortage

• James Alexander has amyl nitrite inhalation on shortage due to manufacturing issues. Estimated Resupply Dates

• James Alexander has amyl nitrite inhalation on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=505 Amphetamine Mixed Salts, Immediate-Release Tablets April 22, 2020 Reason for the Shortage

• Aurobindo refuses to provide updated availability information. • Sun Pharma discontinued amphetamine mixed salts in 2019. • Zydus did not provide a reason for the shortage. • Mylan did not provide a reason for the shortage • Teva has brand name Adderall and generic amphetamine mixed salts available. • Mallinckrodt has amphetamine mixed salts available.

Estimated Resupply Dates • Mylan has amphetamine mixed salts 5 mg, 7.5 mg, 10 mg, 12.5mg, 15 mg, 20 mg, and 30 mg

immediate release tablets on back order and the company cannot estimate a release date. • Zydus has amphetamine mixed salts 7.5 mg, 12.5 mg, and 15 mg tablets on back order and the

company estimates release dates of early-May 2020 for 7.5 mg and 15 mg tablets and late-April to early-May 2020 for the 12.5 mg tablets. All other presentations are on allocation.



5% Dextrose Injection (PVC-free and DEHP-free) April 22, 2020 Reason for the Shortage

• Baxter has 5% dextrose PVC/DEHP-free Viaflo bags available. • BBraun had 5% dextrose PVC/DEHP-free bags on shortage due to manufacturing delays. • BD has 5% dextrose PVC/DEHP-free bags available. • Fresenius Kabi did not provide a reason for the shortage. • ICU Medical has 5% dextrose PVC/DEHP-free bags available.

Estimated Resupply Dates • Fresenius Kabi has 5% dextrose in 100 mL PVC/DEHP-free bags available with short expiration

dating (< 5 months). https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=314 Nicardipine Hydrochloride Injection April 24, 2020 Reason for the Shortage

• Baxter recently acquired Cardene from Chiesi. They have Cardene available. They are not marketing Cardene 20 mg/200 mL in 5% dextrose premixed bags.

• Hikma did not provide a reason for the shortage. • Mylan discontinued nicardipine vials. • Sun Pharma discontinued nicardipine ampules. • Chiesi discontinued Cardene 40 mg/200 mL in 5% dextrose premixed bags in mid-2019.

Estimated Resupply Dates • Hikma has nicardipine 2.5 mg/mL 10 mL vials on allocation. • Hikma has nicardipine 20 mg/200 mL and 40 mg/200 mL in 0.9% sodium chloride premixed bags

on back order with an estimated release date of late-April 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=574 Triamcinolone Acetonide Intravitreal Injection April 22, 2020 Reason for the Shortage

• Novartis has Triesence on shortage due to manufacturing delays. Estimated Resupply Dates

• Novartis has Triesence 40 mg/mL 1 mL vials on limited allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=598 Tacrolimus Injection April 27, 2020 Reason for the Shortage

• Astellas did not provide a reason for the shortage. Estimated Resupply Dates

• Astellas has Prograf 5 mg/mL 1 mL ampules on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=588


Tacrolimus Extended-Release Capsules and Tablets April 27, 2020 Reason for the Shortage

• Astellas has Astagraf XL capsules on allocation. • Veloxis has Envarsus XR tablets available.

Estimated Resupply Dates • Astellas has Astagraf XL available on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=595 Lithium Oral Solution April 27, 2020 Reason for the Shortage

• Hikma has lithium oral solution on shortage due to a raw ingredient shortage. Estimated Resupply Dates

• Hikma has lithium oral solution on back order and the company cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=655 Hydroxyzine Pamoate Oral Capsules April 27, 2020 Reason for the Shortage

• Amneal has hydroxyzine pamoate capsules available. • Avet (formerly Heritage) did not provide a reason for the shortage. • Mylan discontinued hydroxyzine pamoate capsules in May 2019. • Pfizer did not provide a reason for the shortage. • Sandoz has hydroxyzine pamoate capsules available. • Teva did not provide a reason for the shortage.

Estimated Resupply Dates • Avet has hydroxyzine pamoate capsules on allocation • Pfizer has Vistaril 25 mg capsules in 100 count bottles on back order and the company estimates

a release date of July 2020. • Teva has hydroxyzine pamoate capsules on intermittent back order and the company is

releasing supplies as they become available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=545 Fluconazole Injection April 27, 2020 Reason for the Shortage

• Baxter did not provide a reason for the shortage. • Hikma discontinued fluconazole injection in August 2018. • Pfizer has fluconazole injection available. The 200 mg/100 mL fluconazole in dextrose bags were

discontinued in August 2018. • Sagent had fluconazole injection available. • Woodward Pharma acquired fluconazole in sodium chloride from Renaissance Lakewood

Pharmaceuticals in August 2019. The 10 count sizes have been discontinued. Estimated Resupply Dates

• Baxter has fluconazole 200 mg/100 mL and 400 mg/200 mL premixed bags on allocation.


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=318 Doxorubicin Injection April 27, 2020 Reason for the Shortage

• Hikma did not provide a reason for the shortage.[1] • Teva had doxorubicin solution for injection available. They discontinued doxorubicin

presentations with NDCs starting in 00703 in early-January 2019.[2-3] • Fresenius Kabi has doxorubicin available.[4] • Caraco has discontinued doxorubicin solution for injection 25 mL and 100 mL vials.[5] • Pfizer has doxorubicin available.[6] • Sagent did not provide a reason for the shortage.[7] • Mylan Institutional discontinued doxorubicin 10 mg lyophilized powder for injection in early

2019. The 50 mg vials are available.[8] • Athenex did not provide a reason for the shortage.[9]

Estimated Resupply Dates • Athenex has doxorubicin 2 mg/mL 25 mL vials on back order and the company cannot estimate

a release date.[9] • Hikma has short-dated doxorubicin 2 mg/mL 5 mL vials available with an expiration date of

February 2021. There are short-dated 10 mL and 25 mL vials available with an expiration date of March 2021. The 100 mL vials are on allocation.[1]

• Sagent has short-dated doxorubicin 2 mg/mL 25 mL vials available with an expiration date of August 2020. There are short-dated 5 mL and 100 mL vials available with an expiration date of September 2020.[7]

• Teva has doxorubicin 2 mg/mL 100 mL vials on back order and the company estimates a release date of May 2020.[2]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=108 Caffeine and Sodium Benzoate Injection April 27, 2020 Reason for the Shortage

• American Regent did not provide a reason for the shortage. Estimated Resupply Dates

• American Regent has caffeine and sodium benzoate 125 mg/mL in 2 mL vials available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=630 Acetazolamide Injection April 27, 2020 Reason for the Shortage

• Hikma did not provide a reason for the shortage. • Mylan Institutional has acetazolamide sodium injection available. • X-Gen did not provide a reason for the shortage.

Estimated Resupply Dates • Hikma has acetazolamide sodium 500 mg vials on allocation. • X-Gen has acetazolamide sodium 500 mg vials on allocation.



5% Lidocaine and 7.5% Dextrose Injection April 27, 2020 Reason for the Shortage

• Pfizer has 5% lidocaine and 7.5% dextrose 2 mL ampules on shortage due to manufacturing delays.

• Pfizer is the sole supplier of this combination. Estimated Resupply Dates

• Pfizer has 5% lidocaine and 7.5% dextrose 2 mL ampules on long-term back order and the company estimates a release date of January 2021.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=253 Ropivacaine Injection April 28, 2020 Reason for the Shortage

• Akorn had ropivacaine on shortage due to increased demand. • AuroMedics did not provide a reason for the shortage. • Fresenius Kabi has Naropin on shortage due to increased demand and manufacturing delays. • Pfizer had ropivacaine on shortage due to manufacturing delays. • Sagent has ropivacaine premixed bags available. • Somerset Therapeutics has ropivacaine 5 mg/mL 30 mL vials available.

Estimated Resupply Dates • AuroMedics has short-dated ropivacaine 10 mg/mL 10 mL and 20 mL vials available with an

expiration date of February 2021 for the 10 mL vials and August 2020 for the 20 mL vials. • Fresenius Kabi has Naropin 5 mg/mL 30 mL Steripak ampules on back order and the company

cannot estimate a release date. The 2 mg/mL 100 mL and 200 mL bottles are on back order and the company estimates a release date of mid-May 2020.

• Pfizer has short-dated ropivacaine 10 mg/mL 10 mL vials available with an expiration date of June 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=384 Hypromellose Ophthalmic Solution April 28, 2020 Reason for the Shortage

• Akorn has Gonak on shortage due to lack of raw materials.1 • HUB Pharmaceuticals is planning on relaunching Goniovisc in late-2020.2 • Altaire has Goniotaire on shortage due to a voluntary recall.[3] • OcuSoft did not provide a reason for the shortage.[4]

Estimated Resupply Dates • Akorn has Gonak 2.5% ophthalmic solution 15 mL bottles on allocation.1 • Altaire has Goniotaire 2.5% ophthalmic solution 15 mL bottles on back order and the company

cannot estimate a release date.[3] • Hub Pharmaceuticals has Goniovisc on long-term back order and the company estimates a

relaunch date of early-2021.[2] • OCuSOFT has Goniosoft 2.5% ophthalmic solution on back order and the company cannot

estimate a release date.4


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=437 Fluorometholone Ophthalmic Ointment April 28, 2020 Reason for the Shortage

• Allergan did not provide a reason for the shortage. They are the sole suppliers of fluorometholone ointment.

• Fluorometholone ophthalmic suspension is not affected by this shortage. Estimated Resupply Dates

• Allergan has FML ophthalmic ointment on long-term back order and the company estimates a release date of late-June 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=613 Fluorescein Ophthalmic Strips April 28, 2020 Reason for the Shortage

• Hub has Bio-Glo on shortage due to shipping delays. • Akorn did not provide a reason for the shortage.

Estimated Resupply Dates • Akorn has Ful-Glo 0.6 mg strips on allocation. The 1 mg strips are temporarily unavailable and

the company cannot estimate a release date. • Hub has Bio-Glo 1 mg strips in 100 count on back order and the company estimates a release

date of late-July 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=362 Temazepam Capsules April 29, 2020 Reason for the Shortage

• Ascend did not provide a reason for the shortage. • Major had temazepam on shortage due to manufacturing delays. • Mylan did not provide a reason for the shortage. • Sun Pharma discontinued temazepam capsules in 2019. • Teva did not provide a reason for the shortage. • Mallinckrodt has Restoril capsules available. • Mylan Institutional discontinued temazepam capsules in unit-dose packaging.

Estimated Resupply Dates • Ascend has temazepam 15 mg and 30 mg capsules in 500 count bottles on intermittent back

order and the company is releasing supplies as they become available. • Mylan has all presentations of temazepam capsules on back order and the company cannot

estimate a release date. • Teva has temazepam 15 mg in 100 and 500 count and 30 mg in 500 count on intermittent back

order and the company is releasing supplies as they become available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=503


Prochlorperazine Maleate Tablets April 29, 2020 Reason for the Shortage

• Cadista had prochlorperazine maleate tablets on shortage due to increased demand.[1] • Mylan did not provide a reason for the shortage.[2] • Mylan Institutional discontinued the prochlorperazine maleate unit-dose presentations in

August 2019.[2] Estimated Resupply Dates

• Mylan has prochlorperazine maleate 5 mg and 10 mg tablets in 100 count bottles on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=549 Octreotide Injection April 30, 2020 Reason for the Shortage

• Fresenius Kabi did not provide a reason for the shortage. • Hikma did not provide a reason for the shortage. • Mylan Institutional has octreotide available. • Sagent has octreotide on shortage due to manufacturing delay. • Sun Pharma is not currently marketing octreotide. • Teva did not provide a reason for the shortage. • Novartis has Sandostatin available. The 200 mcg/mL 5 mL vials were discontinued in early-2018.

Estimated Resupply Dates • Hikma has octreotide 100 mcg/mL 1 mL vials and 500 mcg/mL 1 mL vials on back order and the

company estimates a release date of late-June to early-July 2020. The 50 mcg/mL 1 mL vials are on back order and the company estimates a release date in late-October 2020.

• Sagent has octreotide 50 mcg/mL 1 mL vials, 100 mcg/mL 1 mL vials, 500 mcg/mL 1 mL vials, and 1,000 mcg/mL 5 mL vials on back order and the company estimates a release date of January 2021.

• Teva has octreotide 50 mcg/mL 1 mL vials, 100 mcg/mL 1 mL vials, 200 mcg/mL 5 mL vials, and 1,000 mcg/mL 5 mL vials on back order and the company estimates a release date of June 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=229 Labetalol Injection April 30, 2020 Reason for the Shortage

• Akorn did not provide a reason for the shortage.[1] • Alvogen did not provide a reason for the shortage.[2] • Fosun has labetalol injection available.[3] • Hikma has labetalol injection on shortage due to increase demand.[4] • Pfizer has labetalol injection on shortage due to manufacturing delays.[5]

Estimated Resupply Dates • Hikma has labetalol 5 mg/mL 20 mL vials on allocation. The 40 mL vials are on back order and

the company estimates a release date of late-June to early-July 2020.[4]


• Pfizer has labetalol 5 mg/mL 20 mL vials available in limited supply. The 40 mL vials are on back order and the company estimates a release date of January 2021. The 5 mg/mL 20 mL vials and 4 mL Carpuject syringes are available in limited supply.[5]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=286 Ketamine Injection April 30, 2020 Reason for the Shortage

• Hikma did not provide a reason for the shortage. • Mylan Institutional did not provide a reason for the shortage. • Par has Ketalar available. • Pfizer has ketamine on shortage due to manufacturing delays.

Estimated Resupply Dates • Hikma has ketamine 50 mg/mL 10 mL vials and 100 mg/mL 5 mL vials on back order and the

company estimates a release date of late-June to early-July 2020. • Mylan Institutional has ketamine 10 mg/mL 20 mL vials on back order and the company

estimates a release date of mid- to late-May 2020. The 100 mg/mL 10 mL vials on back order and the company estimates a release date of mid-June 2020.

• Pfizer has ketamine 50 mg/mL 10 mL vials on back order and the company estimates a release date of June 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=391 Gentamicin Injection April 30, 2020 Reason for the Shortage

• Baxter has gentamicin premixes available. • Fresenius Kabi has gentamicin injection available. • Pfizer has gentamicin on shortage due to manufacturing delays.

Estimated Resupply Dates • Pfizer has gentamicin 40 mg/mL 2 mL vials on back order and the company estimates a release

date of June 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=637 Famotidine Injection April 30, 2020 Reason for the Shortage

• Baxter has famotidine injection on shortage due to manufacturing delays. • Fresenius Kabi did not provide a reason for the shortage. • Hikma did not provide a reason for the shortage. • Mylan Institutional did not provide a reason for the shortage.

Estimated Resupply Dates • Baxter has famotidine 20 mg/50 mL premixed bags on back order and the company cannot

estimate a release date. • Fresenius Kabi has famotidine 10 mg/mL 2 mL, 4 mL, and 20 mL vials on back order and the

company estimates a release date of early-May 2020 for the 2 mL and 4 mL vials and late-May 2020 for the 20 mL vials.


• Hikma has famotidine 10 mg/mL 2 mL and 4 mL vials on back order and the company estimates a release date of early-May 2020 for the 2 mL vials and late-June to early-July 2020 for the 4 mL vials. The 20 mL vials are on allocation.

• Mylan Institutional has famotidine 10 mg/mL 2 mL and 20 mL vials on back order and the company estimates a release date of mid-June 2020 and mid-May 2020 for the 20 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=656 Buspirone Tablets April 27, 2020 Reason for the Shortage

• Accord has buspirone tablets available. • Apnar did not provide a reason for the shortage. • Mylan Has buspirone tablets available. • Par has buspirone tablets available. • Teva has buspirone tablets available. • Zydus has buspirone tablets available.

Estimated Resupply Dates • Apnar has buspirone 15 mg tablets in 60 count bottles on back order and the company

estimates a release date of mid-2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=465 Sulfasalazine Enteric-Coated and Immediate-Release Tablets May 1, 2020 Reason for the Shortage

• Greenstone did not provide a reason for the shortage. • Teva did not provide a reason for the shortage. • Pfizer has Azulfidine available.

Estimated Resupply Dates • Greenstone has sulfasalazine enteric-coated 500 mg tablets and immediate-release 500 mg

tablets in 100 and 300 count bottles on intermittent back order and the company is releasing supplies as they become available.

• Teva has sulfasalazine immediate-release 500 mg tablets in 100, 500, and 1000 count bottles on intermittent back order and the company is releasing supplies as they become available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=625 Methenamine Hippurate Tablets May 1, 2020 Reason for the Shortage

• Alvogen did not provide a reason for the shortage. • Aurobindo refuses to provide us with availability information. • Amneal discontinued methenamine hippurate in 2018. • Leading Pharma discontinued methenamine hippurate in 2017 due to a raw materials shortage. • Micro Labs has methenamine hippurate on shortage due to increased demand. • Validus Pharmaceuticals did not provide a reason for the shortage.

Estimated Resupply Dates • Alvogen has temporarily discontinued methenamine hippurate tablets.


• Micro Labs has methenamine hippurate tablets on allocation. • Validus has Hiprex on back order and the company cannot estimate an estimated release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=642 Lidocaine Injection May 1, 2020 Reason for the Shortage

• Amphastar had lidocaine 2% emergency syringes available. • AuroMedics introduced lidocaine injection in February 2014. • Fresenius Kabi had generic lidocaine presentations on shortage due to a supply interruption of

raw ingredients. • Pfizer has lidocaine presentations on shortage due to manufacturing delays.

Estimated Resupply Dates • Fresenius Kabi has 1% lidocaine 2 mL vials on back order and the company estimates a release

date of early-June 2020. • Hikma has 1% lidocaine 5 mL and 50 mL vials on allocation. The 2% lidocaine 50 mL vials are on

allocation. • Pfizer has 0.5% lidocaine 50 mL flip top vials on back order and the company estimates a release

date of January 2021. The 1% lidocaine 5 mL preservative-free ampules are on back order and the company estimates a release date of September 2020. The 1% lidocaine 5 mL Ansyr syringes are on back order and the company estimates a release date of December 2020. The 1% lidocaine 5 mL LifeShield syringes are on back order and the company estimates a release date of August 2020. The 2% lidocaine 5 mL LifeShield syringes are available in limited supply. The 2% lidocaine 5 mL Ansyr syringes are on back order and the company estimates a release date of December 2020. There are short-dated 2% lidocaine 2 mL preservative-free ampules available with an expiration date of September 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=88 Irbesartan Tablets May 1, 2020 Reason for the Shortage

• Beginning in mid-2018, FDA found that several angiotensin II receptor blocker (ARB) medicines contained nitrosamine impurities and have been recalled because they do not meet FDA's safety standards. Additional information including a list of affected lots can be found at https://www.fda.gov/drugs/drug-safety-and-availability/recalls-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and-irbesartan.

• Solco and ScieGen were affected by the recall. • Camber, Lupin, and Westminster did not provide a reason for the shortage. • Hikma is not actively marketing irbesartan tablets. • MacLeod's has irbesartan tablets available to contracted customers only. • Sanofi-Aventis has Avapro tablets available. • Repackagers may have some presentations affected depending on the source supplier.

Estimated Resupply Dates • Alembic has irbesartan 150 mg tablets in 30-count bottles and 300 mg tablets in 30-count

bottles on intermittent back order and the company is releasing drug as it becomes available. All other tablet presentations are on back order and the company cannot estimate a release date.


• Lupin has irbesartan tablets on back order and the company cannot estimate a release date. • Solco has irbesartan tablets on long-term back order and the company cannot estimate a

release date. • Westminster has irbesartan tablets on back order and the company cannot estimate a release

date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=580 Hydromorphone Hydrochloride Injection May 1, 2020 Reason for the Shortage

• Akorn has hydromorphone injection available.[1] • Fresenius Kabi has Dilaudid syringes on shortage due to increased demand. They are focusing

their product on the 0.5 mg strength. They launched hydromorphone vials in late-June 2018.[2] • Pfizer has hydromorphone on shortage due to manufacturing delays. The hydromorphone 1

mg/mL 1 mL iSecure syringes and 2 mg/mL 1 mL iSecure syinges were discontinued in February 2020.[3]

• Purdue discontinued Dilaudid and Dilaudid HP in May 2017 for marketing reasons.[4] • Teva did not provide a reason for the shortage.[5] • Hikma did not provide a reason for the shortage.[6]

Estimated Resupply Dates • Fresenius Kabi has hydromorphone 10 mg/mL 1 mL, 5 mL, and 50 mL vials on back order and the

company estimates a release date of mid-June 2020 for the 1 mL vials, late-June 2020 for the 5 mL vials, and early-July 2020 for the 50 mL vials.[2]

• Hikma has hydromorphone 2 mg/mL 20 mL vials on back order and the company estimates a release date of mid-May 2020.[6]

• Pfizer has 10 mg/mL 1 mL vials, 5 mL, and 50 mL vials are on back order and the company estimates a release date of May 2020 for the 1 mL vials, July 2020 for the 5 mL and 50 mL vials. The 0.5 mg/0.5 mL iSecure syringes are available in limited supply. The 1 mg/mL 1 mL Carpuject syringes are available in limited supply. The 2 mg/mL 1 mL ampules are on back order and the company estimates a release date of January 2021. The 2 mg/mL 1 mL vials are on back order and the company estimates a release date of June 2020. The 4 mg/mL 1 mL ampules are on back order and the company estimates a release date of January 2021. The 4 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of May 2020.[3]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=329 Guanfacine Hydrochloride Tablets May 1, 2020 Reason for the Shortage

• Amneal has guanfacine tablets available. • Mylan did not provide a reason for the shortage. • Teva did not provide a reason for the shortage.

Estimated Resupply Dates • Teva has guanfacine 2 mg tablets in 100 count bottles on long-term back order and the company

cannot estimate a release date. • Mylan has guanfacine 1 mg and 2 mg tablets in 100 count bottle on back order and the company

cannot estimate a release date.


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=508 Furosemide Injection May 1, 2020 Reason for the Shortage

• American Regent is not actively marketing furosemide injection. • Amneal discontinued furosemide injection. • AuroMedics has furosemide injection on shortage due to shipping delays. • Avet Pharmaceuticals has furosemide injection available. • Baxter has furosemide injection on shortage due to manufacturing delays and increased

demand. • Fresenius Kabi has furosemide injection on shortage due to increased demand. • Pfizer had furosemide injection on shortage due to manufacturing delays and increased

demand. Estimated Resupply Dates

• AuroMedics has furosemide 10 mg/mL 2 mL, 4 mL, and 10 mL vials on back order and the company estimates a release date of late-May 2020.

• Baxter has furosemide 10 mg/mL 4 mL vials on back order and the company estimates a release date of May 2020. The 2 mL and 10 mL vials are available in limited supply.

• Fresenius Kabi has furosemide 10 mg/mL 2 mL, 4 mL, and 10 mL vials on back order and the company estimates a release date of mid- to late-May 2020 for the 2 mL and 10 mL vials and mid-May 2020 for the 4 mL vials.

• Pfizer has furosemide 10 mg/mL 4 mL and 10 mL syringes on back order and the company estimates a release date of June 2020. The 4 mL vials are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=323 Buprenorphine Hydrochloride Injection May 1, 2020 Reason for the Shortage

• Pfizer has buprenorphine injection on shortage due to manufacturing delays. • Par had buprenorphine injection on shortage due to increased demand.

Estimated Resupply Dates • Pfizer has buprenorphine 0.3 mg/mL 1 mL Carpuject syringes on back order and the company

estimates a release date of May 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=419 Atropine Sulfate Injection May 1, 2020 Reason for the Shortage

• American Regent had atropine injection on shortage due to market demand. • Amphastar has atropine injection on shortage due to increased demand. • Fresenius Kabi has atropine injection available. • Hikma has atropine injection available. • Pfizer has atropine injection on shortage due to manufacturing delays.



• American Regent has atropine 0.4 mg/mL 1 mL vials and 1 mg/mL 1 mL vials available in limited supply.

• Hikma has atropine 0.4 mg/mL 20 mL vials on allocation. • Pfizer has atropine 0.1 mg/mL 5 mL and 10 mL LifeShield syringes available in limited supply. The

0.1 mg/mL 10 mL Ansyr syringes are available in limited supply. The 0.05 mg/mL 5 mL Ansyr syringes are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=46 50% Dextrose Injection May 1, 2020 Reason for the Shortage

• Amphastar has 50% dextrose injection on allocation due to increased demand. • Pfizer has 50% dextrose injection on shortage due to manufacturing delays.

Estimated Resupply Dates • Pfizer has 50% dextrose 50 mL LifeShield syringes available in limited supply. The 50% dextrose

50 mL Ansyr syringes are available in limited supply. The 50% dextrose 50 mL vials are on back order and the company estimates a release date of May 2020.

• Amphastar has 50% dextrose 50 mL Luer-Jet syringes on allocation with regular releases. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=306 Sodium Polystyrene Sulfone Powder May 4, 2020 Reason for the Shortage

• CMP Pharma has sodium polystyrene sulfonate on back order due to a raw material shortage. They are using available powder to make suspension.

• ECI Pharmaceuticals has sodium polystyrene sulfonate powder available. • KVK-Tech has sodium polystyrene sulfonate powder on allocation to ensure equal distribution of

supplies. • Marlex has sodium polystyrene sulfonate powder available. • Sunrise Pharmaceuticals has sodium polystyrene sulfonate powder available. • Trigen has sodium polystyrene sulfonate powder available.

Estimated Resupply Dates • CMP Pharma has sodium polystyrene sulfonate in 454 gram bottles on back order and the

company cannot estimate a release date. • KVK-Tech has sodium polystyrene sulfonate powder on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=523 Sodium Polystyrene Sulfonate Oral or Rectal Suspension May 4, 2020 Reason for the Shortage

• CMP Pharma reports that increased demand has led to a shortage of raw material required to manufacture the products. They are using available powder to manufacture the suspension.

• Perrigo has temporarily discontinued their Kionex suspension and sodium polystyrene sulfonate (sorbitol-free) suspension. They cannot estimate when these products will be manufactured again.

• Hikma is not currently marketing sodium polystyrene sulfonate suspension.


Estimated Resupply Dates • CMP Pharma has SPS Suspension on allocation and the company is shipping supplies regularly.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=430 Sodium Acetate Injection May 4, 2020 Reason for the Shortage

• American Regent is not currently marketing sodium acetate injection. • Fresenius Kabi has sodium acetate injection available. • Pfizer had sodium acetate injection on shortage due to manufacturing delays.

Estimated Resupply Dates • All marketed presentations are available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=317 Magnesium Sulfate Injection May 4, 2020 Reason for the Shortage

• American Regent is not currently marketing magnesium sulfate which has been unavailable since late 2012.

• Fresenius Kabi had magnesium sulfate injection on shortage due to increased demand for the product.

• Pfizer has magnesium sulfate injection on shortage due to manufacturing delays. • X-Gen discontinued magnesium sulfate in April 2018. • Exela launched magnesium sulfate vials in May 2018. • WG Critical Care had magnesium sulfate injection on shortage due to increased demand for the

product. Estimated Resupply Dates

• Fresenius Kabi has magnesium sulfate 40 mg/mL 50 mL and 100 mL premixed bags on back order and the company estimates a release date of mid-May 2020 for the 50 mL bags and late-May 2020 for the 100 mL bags. The 10 mg/mL 100 mL premixed bags are on back order and the company estimates a release date of mid-May 2020. The 80 mg/mL 50 mL premixed bags are on back order and the company estimates a release date of mid-June 2020. The 500 mg/mL 2 mL vials are on back order and the company estimates a release date of early- to mid-June 2020. There are short-dated 500 mg/mL 2 mL vials and 80 mg/mL 50 mL premixed bags available with an expiration date of <9 months.

• Pfizer has magnesium sulfate 500 mg/mL 20 mL vials on back order and the company estimates a release date of June 2020. The 500 mg/mL 10 mL syringes are on back order and the company estimates a release date of June 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=21 Ketorolac Injection May 4, 2020 Reason for the Shortage

• Alvogen did not provide a reason for the shortage.[1] • Amphastar has discontinued ketorolac injection.[2] • Athenex has ketorolac available.[3]


• BD RX is now part of Fresenius Kabi.[4] • Fresenius Kabi has most ketorolac presentations available.[5] • Fosun Pharma has ketorolac available.[9] • Pfizer has ketorolac injection on back order due to manufacturing delays.[6] • Sagent states the reason for the shortage is manufacturing delay.[7] • Hikma did not provide a reason for the shortage.[8] • Ben Venue closed its plant in Bedford, Ohio in July 2014.[10] • Virtus discontinued ketorolac in March 2019.[11] • FDA imposed an import ban in mid-2013 on several Wockhardt products including ketorolac.[12] • Sprix Nasal Spray is not affected by this shortage.[13]

Estimated Resupply Dates • Almaject has ketorolac 15 mg/mL 1 mL vials and 30 mg/mL 1 mL vials on back order and the

company cannot estimate a release date.1 • Fresenius Kabi has ketorolac 15 mg/mL 1 mL vials on back order and the company estimates a

release date of early-June 2020. The 30 mg/mL 2 mL vials for intramuscular injection are on back order and the company estimates a release date of early- to mid-June 2020.[5]

• Hikma has all ketorolac presentations on back order and the company estimates a release date of late-July 2020.[8]

• Pfizer has ketorolac 30 mg/mL 1 mL Carpuject syringes on back order and the company estimates a release date of January 2021. The 30 mg/mL 2 mL Carpuject syringes for intramuscular injection are on back order and the company estimates a release date of January 2021. The 30 mg/mL 1 mL iSecure syringes are on back order and the company estimates a release date of February 2023.[6]

• Sagent has ketorolac 15 mg/mL 1 mL vials, 30 mg/mL 1 mL vials, and 30 mg/mL 2 mL vials for intramuscular injection on back order and the company estimates a release date of January 2021.[7]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=113 Fluticasone Propionate Oral Inhalers May 4, 2020 Reason for the Shortage

• GlaxoSmithKline is allocating to wholesale customers in an effort to ensure equitable distribution of available product. Customers must place orders through their wholesalers.

• GlaxoSmithKline is the sole supplier of fluticasone propionate inhalers. Estimated Resupply Dates

• GlaxoSmithKline has Flovent Diskus dry powder inhalers on allocation. • GlaxoSmithKline has Flovent HFA aerosol inhalers on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=650 Erythromycin Ophthalmic Ointment May 4, 2020 Reason for the Shortage

• Akorn has erythromycin ophthalmic ointment available. • Bausch Health did not provide a reason for the shortage. • Perrigo had erythromycin ophthalmic ointment on shortage due to increased demand.



• Bausch Health has short-dated erythromycin 0.5% ophthalmic ointment 1 gram tubes with an expiration date of April 2021.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=540 Deferoxamine Injection May 4, 2020 Reason for the Shortage

• Fresenius Kabi had deferoxamine on shortage due to increased demand. • Pfizer had deferoxamine on shortage due to manufacturing delays. • Novartis has Desferal available. • Almaject did not provide a reason for the shortage. Almaject discontinued the 500 mg vials in

late-2019. • Apo-Pharma launched deferoxamine injection in mid-2018.

Estimated Resupply Dates • Almaject has short-dated deferoxamine 2 gram vials available with an expiration date of June

2020. • Fresenius Kabi has deferoxamine 500 mg and 2 gram vials on back order and the company

estimates a release date of mid-June 2020 for the 500 mg vials and late-May 2020 for the 2 gram vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=393 Chlorothiazide Sodium Injection May 4, 2020 Reason for the Shortage

• Akorn has chlorothiazide on allocation due to increased demand. • American Regent did not provide a reason for the shortage. • Fresenius Kabi did not provide a reason for the shortage. • Sagent has chlorothiazide injection on shortage due to manufacturing delays. • Sun Pharma is not marketing chlorothiazide injection.

Estimated Resupply Dates • Akorn has chlorothiazide 500 mg vials and Diuril 500 mg vials on allocation. • Sagent has chlorothiazide 500 mg vials on back order and the company estimates a release date

of May 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=638 Cefoxitin Sodium Injection May 4, 2020 Reason for the Shortage

• Apotex has temporarily discontinued cefoxitin vials. • BBraun has cefoxitin on allocation due to increased demand. • Fresenius Kabi did not provide a reason for the shortage. • Hikma did not provide a reason for the shortage. Hikma is not currently marketing cefoxitin 10

gram vials. • Sagent has cefoxitin on shortage due to increased demand and manufacturing delay. • WG Critical Care did not provide a reason for the shortage.



• Apotex has temporarily discontinued cefoxitin 1 gram, 2 gram, and 10 gram vials and the company cannot estimate when product will be available again.

• BBraun has cefoxitin 1 gram and 2 gram DUPLEX bags on back order and the company cannot estimate a next release date.

• Fresenius Kabi has cefoxitin 1 gram and 2 gram vials on back order and the company estimates a release date of mid-May 2020 for the 1 gram vials and mid-June 2020 for the 2 gram vials.

• Hikma has cefoxitin 1 gram and 10 gram vials on back order and the company estimates a release date late-June to early-July 2020. The 2 gram vials are on back order and the company estimates a release date of late-December 2020 to early-January 2021.

• Sagent has cefoxitin 2 gram and 10 gram vials on back order and the company estimates a release date of May 2020. The 1 gram vials are on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=271 Cefazolin Injection May 4, 2020 Reason for the Shortage

• Apotex has discontinued all presentations except cefazolin 1 gram vials. • Baxter has cefazolin on shortage due to increased demand. • BBraun has cefazolin on shortage due to manufacturing delays. • Fresenius Kabi had cefazolin on shortage due to increased demand. They are not manufacturing

the 20 gram vials at this time to focus on the other sizes. • Hikma did not provide a reason for the shortage. • Pfizer states the reason for the shortage is manufacturing delay. • Sagent states the reason for the shortage is manufacturing delays and increased demand. • Samson Medical Technologies has cefazolin injection available. • Sandoz did not provide a reason for the shortage. • WG Critical Care did not provide a reason for the shortage.

Estimated Resupply Dates • Baxter has cefazolin 2 gram/100 mL premixed bags on allocation. • BBraun has 1 gram/50 mL and 2 gram/50 mL premixed bags on allocation. • Hikma has cefazolin 10 gram vials on allocation. • Pfizer has cefazolin 1 gram vials and 10 gram vials on back order and the company estimates a

release date of February 2023. • Sagent has cefazolin 500 mg vials on allocation. The 1 gram and 10 gram vials are on back order

and the company estimates a release date of June 2020. • WG Critical Care has cefazolin 1 gram vials on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=432 Morphine Injection May 5, 2020 Reason for the Shortage

• Fresenius Kabi procured morphine syringes from BD in 2016. They discontinued the 8 mg/mL and 10 mg/mL 1 mL syringes in early-2018.[1-2]

• Astramorph injection has been unavailable since 2012. Fresenius Kabi changed manufacturing sites and cannot estimate if Astramorph will return.[2]


• Pfizer has a shortage of several prefilled syringe products, including morphine, starting in late-July 2017 due to issues at a manufacturing facility. Pfizer discontinued morphine iSecure syringes in February 2020.[3]

• Hikma did not provide a reason for the shortage.[4] • Piramal Critical Care did not provide a reason for the shortage.[5]

Estimated Resupply Dates • Pfizer has morphine 25 mg/mL 1 mL preservative-free vials are on back order and the company

estimates a release date of November 2020. The 50 mg/mL 20 mL and 50 mL vials are available in limited supply.[3]

• Hikma has morphine 4 mg/mL 1 mL vials on back order and the company cannot estimate a release date. The 10 mg/mL 1 mL vials are on back order and the company estimates a release date of late-May 2020. Duramorph 0.5 mg/mL 10 mL ampules are on back order and the company estimates a release date of late-May 2020.[4]

• Piramal has Mitigo 10 mg/mL 20 mL vials and 25 mg/mL 20 mL vials on back order and the company estimates a release date of late-June to early-July 2020. There are short-dated vials available.[5]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=41 Losartan Tablets May 5, 2020 Reason for the Shortage


• Camber, Heritage, Teva, and Torrent have been affected by the recall. • Alembic has losartan on back order due to manufacturing delays. • Aurobindo refuses to provide updated availability information. • Cadista has temporarily discontinued losartan tablets due to issues with obtaining active

ingredient. • Camber has losartan tablets available. • Lupin, Sandoz, and Zydus did not provide a reason for the shortage. • Major has losartan tablets in unit-dose packages available. • Merck has Cozaar available. • Rising discontinued losartan in August 2019. • Teva discontinued losartan in 2018. • Torrent recalled several lots of losartan tablet presentations due to an impurity found in the

active pharmaceutical ingredient. Additional information can be found at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/updated-torrent-pharmaceuticals-limited-expands-voluntary-nationwide-recall-losartan-potassium.

Estimated Resupply Dates • Alembic has losartan potassium tablets on back order and the company cannot estimate a

release date. • Avet has losartan potassium tablets on back order and the company cannot estimate a release

date.


• Cadista has temporarily discontinued losartan potassium tablets and the company cannot estimate when product will be available again.

• Lupin has losartan potassium tablets on allocation. • Major has losartan potassium 25 mg, 50 mg, and 100 mg unit-dose tablets on back order and

the company cannot estimate a release date. • Sandoz has losartan potassium tablets on back order and the company cannot estimate a

release date. • Zydus has losartan potassium tablets on allocation. • Torrent has losartan potassium tablets on long term back order and the company estimates a

relaunch in 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=572 Dexmedetomidine Hydrochloride 4mcg/mL Premix for Injection May 5, 2020 Reason for the Shortage

• Fresenius Kabi has dexmedetomidine on shortage due to increased demand. • Slayback has dexmedetomidine on shortage due to increased demand. • WG Critical Care has dexmedetomidine on shortage due to increased demand. • Pfizer has Precedex on shortage due to increased demand.

Estimated Resupply Dates • Fresenius Kabi has dexmedetomidine 4 mcg/mL in 0.9% sodium chloride 50 mL and 100 mL

bottles on back order and the company estimates a release date of mid-May 2020. The 20 mL vials are on back order and the company estimates a release date of mid-May 2020.

• Slayback has dexmedetomidine 4 mcg/mL in 0.9% sodium chloride 50 mL and 100 mL plastic bottles on allocation.

• WG Critical Care has dexmedetomidine 4 mcg/mL in 5% dextrose 50 mL and 100 mL premixed bags on back order and the company estimates a release date of mid-May 2020.

• Pfizer has Precedex 4 mcg/mL in 0.9% sodium chloride 50 mL bottles on back order and the company estimates a release date of July 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=653 Ceftazidime Injection May 5, 2020 Reason for the Shortage

• Pfizer has Tazicef available. • Sagent has ceftazidime injection on shortage due to increased demand and manufacturing

delays. • BBraun has ceftazidime on allocation due to increased demand. • Teligent estimates to relaunch Fortaz in June. • WG Critical Care has ceftazidime available.

Estimated Resupply Dates • BBraun has ceftazidime 1 gram/50 mL and 2 gram/50 mL premixed bags on allocation. • Pfizer has Tazicef 1 gram vials on back order and the company estimates a release date of May

2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=63


Asparaginase Erwinia chrysanthemi May 5, 2020 Reason for the Shortage

• Erwinaze supply disruption is due to ongoing manufacturing issues and capacity constraints at Porton Biopharma Limited, the sole manufacturer of Erwinaze. Erwinaze is distributed by Jazz Pharmaceuticals.

Estimated Resupply Dates • Jazz Pharmaceuticals has Erwinaze 10,000 unit vials in 1 count and 5 count on back order and

the company estimates product will be available in mid-May 2020. • There is a new process for ordering Erwinaze. Additional information regarding the new

ordering process is available at www.erwinazesupply.com. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=482 Argatroban Injection May 5, 2020 Reason for the Shortage

• AuroMedics has argatroban available. • Chiesi has argatroban available. • Fresenius Kabi did not provide a reason for the shortage. • Hikma has argatroban available. • Mylan Institutional did not provide a reason for the shortage. • Par has argatroban available. • Pfizer did not provide a reason for the shortage. • Sandoz discontinued argatroban 1 mg/mL 50 mL vials in April 2019. Sandoz discontinued

argatroban 1 mg/mL 125 mL vials in April 2020. • Teva has argatroban temporarily unavailable.

Estimated Resupply Dates • Mylan has argatroban 100 mg/mL 2.5 mL vials on back order and the company estimates a

release date of mid-June 2020. • Pfizer has argatroban 100 mg/mL 2.5 mL vials available in limited supply. • Teva has temporarily discontinued argatroban 1 mg/mL 250 mL premixed bags.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=494 Aminocaproic Acid Injection May 5, 2020 Reason for the Shortage

• American Regent did not provide a reason for the shortage. • Pfizer has aminocaproic acid injection on shortage due to increased demand.

Estimated Resupply Dates • American Regent has aminocaproic acid 250 mg/mL 20 mL vials available in limited supply. • Pfizer has aminocaproic acid 250 mg/mL 20 mL vials available in limited supply.



Acetylcysteine Oral and Inhalation Solution May 5, 2020 Reason for the Shortage

• American Regent has acetylcysteine oral and inhalation solution on shortage due to manufacturing delays.

• Arbor discontinued Cetylev effervescent tablets in April 2019. • Fresenius Kabi did not provide a reason for the shortage. • Pfizer has acetylcysteine oral and inhalation solution on shortage due to manufacturing delays. • Roxane Labs discontinued acetylcysteine oral and inhalation solution in April 2014.

Estimated Resupply Dates • American Regent has acetylcysteine solution 200 mg/mL 30 mL vials on back order and the

company cannot estimate a release date. • Pfizer has acetylcysteine solution 200 mg/mL 30 mL vials on back order and the company

estimates a release date of May 2020. • Fresenius Kabi has acetylcysteine solution 200 mg/mL 10 mL and 30 mL vials on back order and

the company estimates a release date of mid-June 2020 for the 10 mL vials and mid-May 2020 for the 30 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=43 0.9% Sodium Chloride Small Volume Bags (<150 mL) May 5, 2020 Reason for the Shortage

• Baxter is allocating 0.9% sodium chloride small volume bags due to increased demand. • BBraun has 0.9% sodium chloride small volume bags available. • BD did not provide a reason for the shortage. • Fresenius Kabi did not provide a reason for the shortage. • ICU Medical states the shortage was due to manufacturing delay. • Pfizer had 0.9% sodium chloride small volume presentations on shortage due to increased

demand. Estimated Resupply Dates

• Baxter has 0.9% sodium chloride 50 mL and 100 mL Viaflex minibags on back order and the company is allocating product as it becomes available. All other presentations are on allocation.

• BD has 0.9% sodium chloride 50 mL and 100 mL PVC/DEHP-free bags on allocation. • Fresenius Kabi has 0.9% sodium chloride 50 mL PVC/DEHP-free bags in 60 count available with

short expiration dating (<4 months). The 100 mL PVC/DEHP-free bags in 50 count are also available with short expiration dating (<9 months).

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=352 Vecuronium Bromide Injection May 6, 2020 Reason for the Shortage

• AuroMedics did not provide a reason for the shortage.[1] • Pfizer has vecuronium on shortage due to increased demand.[2] • Teva has vecuronium available.[3] • Mylan Institutional did not provide a reason for the shortage.[4] • Sun Pharma has vecuronium on shortage due to increased demand.[5]


• Fresenius Kabi has vecuronium on shortage due to increased demand.[6] Estimated Resupply Dates

• AuroMedics has vecuronium 10 mg and 20 mg vials on back order and the company cannot estimate a release date.[1]

• Fresenius Kabi has vecuronium 10 mg and 20 mg vials on back order and the company estimates a release date of mid-July 2020 for the 10 mg vials and mid-August 2020 for the 20 mg vials.[6]

• Mylan Institutional has vecuronium 10 mg and 20 mg vials on back order and the company estimates a release date of late-July 2020.[4]

• Pfizer has vecuronium 10 mg and 20 mg vials available in limited supply.[2] • Sun Pharma has vecuronium 10 mg and 20 mg vials on allocation.[5]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=167 Tropicamide 1% Ophthalmic Solution May 6, 2020 Reason for the Shortage

• Akorn did not provide a reason for the shortage of tropicamide 1% ophthalmic drops. • Alcon has Mydriacyl available. • Bausch Health did not provide a reason for the shortage. • Sandoz did not provide a reason for the shortage of tropicamide 1% ophthalmic drops.

Estimated Resupply Dates • Bausch Health has 1% tropicamide 2 mL bottles on back order and the company estimates a

release date of early-June 2020. • Sandoz has 1% tropicamide 3 mL bottles on back order and the company estimates a release

date of early-June 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=547 Sodium Bicarbonate Injection May 6, 2020 Reason for the Shortage

• Amphastar has sodium bicarbonate injection on shortage due to increased demand.[1] • Athenex has sodium bicarbonate available.[2] • Exela has sodium bicarbonate available.[3] • Fresenius Kabi has sodium bicarbonate available.[4] • Pfizer has sodium bicarbonate injection on shortage due to manufacturing delays. The Neut vials

were discontinued in December 2019.[5] Estimated Resupply Dates

• Amphastar has 8.4% sodium bicarbonate 50 mL syringes on allocation.[1] • Pfizer has 4.2% sodium bicarbonate 10 mL syringes available in limited supply. The 7.5% 50 mL

syringes are on back order and the company estimates a release date of May 2020. The 8.4% sodium bicarbonate 50 mL LifeShield syringes are available in limited supply. There are short-dated 8.4% sodium bicarbonate 10 mL syringes available with an expiration date of July 2020.[5]



Prednisone Oral Tablets May 6, 2020 Reason for the Shortage

• Cadista, Hikma, and Par did not provide a reason for the shortage. • Teva has prednisone tablets on shortage due to manufacturing delays.

Estimated Resupply Dates • Cadista has all prednisone tablet presentations available. Cadista recently discontinued the 10

mg tablets in 500 count bottles and the 20 mg tablets in 1000 count bottles. • Hikma has prednisone 1 mg tablets in 100 count unit-dose packages and 1000 count bottles, 5

mg tablets in 1000 count bottles, 20 mg tablets in 100 count and 500 count bottles, and 50 mg tablets in 100 count bottles on allocation.

• Par has prednisone 10 mg tablets in 21-count blister packs on back order and the company estimates a release date in mid-May 2020.

• Teva has prednisone 5 mg and 10 mg tablets in 21 and 48 count blister packs on intermittent back order and the company is releasing supplies as they become available. The 20 mg tablets in 100 count bottles are also on intermittent back order and the company is releasing supplies as they become available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=563 Neomycin and Polymixin B Sulfates Genitourinary Irrigant May 6, 2020 Reason for the Shortage

• X-Gen did not provide a reason for the shortage. • Pfizer has discontinued Neosporin ampules.

Estimated Resupply Dates • X-Gen has neomycin and polymyxin B sulfate 40 mg - 200,000 unit/mL 1 mL ampules in 10 and

50 count boxes on back order and the company estimates a release date in mid-May 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=621 Mineral Oil and Petrolatum Ophthalmic Ointment May 6, 2020 Reason for the Shortage

• Allergan has Refresh PM and Lacri-Lube SOP available. The Lacri-Lube SOP 7 gram tubes have been discontinued.

• Bausch Health has Soothe Night Time ointment available. • Major did not provide a reason for the shortage. • Alcon states the shortage was due to manufacturing issues and increased demand.

Estimated Resupply Dates • Major has Lubrifresh PM in 3.5 gram tubes on back order and the company cannot estimate a

release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=435


Famotidine Tablets May 6, 2020 Reason for the Shortage

• Alembic has famotidine tablets on allocation due to increased demand. • Mylan discontinued famotidine tablets in all presentations in April 2019. • Teva did not provide a reason for the shortage. • Aurobindo refuses to provide availability information. • Dr. Reddy's discontinued famotidine tablets in all presentations. • Bausch Health did not provide a reason for the shortage.

Estimated Resupply Dates • Bausch has short-dated Pepcid 20 mg tablets in 30 count and 100 count bottles and 40 mg

tablets in 30 count bottles with an expiration date of March 2021. • Teva has all famotidine tablets on back order with an estimated release date of 4th quarter

2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=616 Diltiazem Hydrochloride Injection May 6, 2020 Reason for the Shortage

• Akorn states the reason for the shortage was increased demand due to market conditions. They are not currently producing the 25 mL vials in 10 count.

• Athenex has diltiazem injection available. • Pfizer states the reasons for the shortage is manufacturing delays and increases in demand. • Hikma has diltiazem injection on shortage due to manufacturing delays caused by increased

demand due to current market conditions. Estimated Resupply Dates

• Akorn has diltiazem 5 mg/mL 5 mL and 25 mL vials on back order and the company cannot estimate a release date. The 10 mL vials are on back order and the company estimates a release date of mid-May 2020.

• Hikma has diltiazem 5 mg/mL 5 mL, 10 mL, and 25 mL vials on allocation. • Pfizer has 5 mg/mL 5 mL vials are on back order and the company estimates a release date of

August 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=26 Chloroquine Phosphate Tablets May 6, 2020 Reason for the Shortage

• Rising did not provide a reason for the shortage. • Sun did not provide a reason for the shortage.

Estimated Resupply Dates • Rising has chloroquine phosphate 250 mg tablets on intermittent back order and the company is

allocating product as it becomes available. • Sun Pharma has chloroquine phosphate 250 mg tablets on back order and the company cannot

estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=640


Albuterol Sulfate Metered Dose Inhalers May 6, 2020 Reason for the Shortage

• GlaxoSmithKline is allocating to wholesale customers in an effort to ensure equitable distribution of available product. Customers must place orders through their wholesalers.

• Merck has Proventil HFA inhalers available. • Par has albuterol HFA inhalers on shortage due to increased demand. • Prasco is allocating product due to increased demand. • Teva did not provide a reason for the shortage. Teva's dry powder inhalers (ProAir Respiclick and

ProAir Digihaler) are not affected by this shortage. Estimated Resupply Dates

• GlaxoSmithKline has Ventolin HFA 8 gram inhalers on back order and the company estimates a release date in late-3rd quarter 2020. Ventolin HFA 18 gram inhalers are on allocation.

• Par has albuterol sulfate HFA 6.7 gram inhalers on back order and the company estimates a release date in mid-May 2020.

• Prasco has albuterol sulfate HFA 18 gram inhalers on allocation. • Teva has ProAir HFA 8.5 gram inhalers on allocation. • Teva has albuterol sulfate HFA 8.5 gram inhalers on intermittent back order and the company is

releasing supplies as they become available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=647 Valproate Sodium Injection May 7, 2020 Reason for the Shortage

• Hikma did not provide a reason for the shortage. • Fresenius Kabi has valproate sodium on shortage due to increased demand.

Estimated Resupply Dates • Fresenius Kabi has valproate sodium 100 mg/mL 5 mL vials on back order and the company

estimates a release date of early-June 2020. • Hikma has valproate sodium 100 mg/mL 5 mL vials on back order and the company estimates a

release date of late-May 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=657 Simethicone Oral Liquid May 7, 2020 Reason for the Shortage

• Geri-Care did not provide a reason for the shortage. • GSK Consumer Healthcare discontinued Baby Gas-X simethicone oral solution. • Major did not provide a reason for the shortages. • Perrigo did not provide a reason for the shortage. • Rugby did not provide a reason for the shortage.

Estimated Resupply Dates • Geri-Care has simethicone 20 mg/0.3 mL oral suspension in 30 mL bottles on back order and the

company estimates a release date of early-June 2020. • Major has simethicone 20 mg/0.3 mL oral suspension in 30 mL bottles on back order and the

company estimates a release date of late-May 2020.


• Perrigo has simethicone 20 mg/0.3 mL oral suspension in 30 mL bottles on back order and the company cannot estimate a release date.

• Rugby has simethicone 20 mg/0.3 mL oral suspension in 30 mL bottles on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=632 Promethazine Injection May 7, 2020 Reason for the Shortage

• Hikma did not provide a reason for the shortage. • X-Gen has promethazine injection available.

Estimated Resupply Dates • Hikma has promethazine 25 mg/mL 1 mL vials on back order and the company estimates a

release date of mid-May 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=460 Enoxaparin Sodium Injection May 7, 2020 Reason for the Shortage

• Amphastar has enoxaparin available. • Apotex launched enoxaparin in early-2019. • Fresenius Kabi did not provide a reason for the shortage. Fresenius Kabi updated NDC numbers

of the 80 mg and 100 mg prefilled syringes in October 2019. • Sandoz discontinued enoxaparin presentations in mid-2018 due to a supplier issue. • Sanofi-Aventis did not provide a reason for the shortage. • Teva has enoxaparin available. • Winthrop has enoxaparin available.

Estimated Resupply Dates • Fresenius Kabi has enoxaparin 120 mg/80 mL 0.8 mL prefilled syringes available with short

expiration dating (< 5 months). • Sanofi-Aventis has Lovenox 150 mg/mL 1 mL and 30 mg/0.3 mL prefilled syringes on back order

and the company cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=466 Docusate Sodium Oral Liquid in Bulk Bottles May 7, 2020 Reason for the Shortage

• Akorn has Docu Liquid on shortage because they are waiting on raw ingredients. • Geri-Care had a contract manufacturer shut down. The company has discontinued Diocto syrup

and liquid. • Lannett did not provide a reason for the shortage. • Docusate sodium 10 mL unit dose cups are not affected.

Estimated Resupply Dates • Akorn has Docu Liquid on intermittent back order and the company is allocating product as it

becomes available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=585


Dexrazoxane Injection May 7, 2020 Reason for the Shortage

• Cumberland Pharmaceuticals relaunched Totect in late-July 2017. • Fosun Pharma has dexrazoxane available. • Hikma did not provide a reason for the shortage. • Mylan Institutional has dexrazoxane available. • Pfizer states manufacturing delay as the reason for the shortage.

Estimated Resupply Dates • Hikma has dexrazoxane 250 mg vials on back order and the company estimates a release date of

mid-May 2020. • Pfizer has Zinecard 500 mg vials on back order and the company estimates a release date of

August 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=107 Dexmedetomidine Hydrochloride 100 mcg May 7, 2020 Reason for the Shortage

• Accord did not provide a reason for the shortage. • Akorn is no longer manufacturing dexmedetomidine vials. • Athenex has dexmedetomidine vials available. • AuroMedics did not provide a reason for the shortage. • Fresenius Kabi did not provide a reason for the shortage. • Hikma did not provide a reason for the shortage. • Mylan did not provide a reason for the shortage. • Par has dexmedetomidine vials on shortage due to increased demand. • Pfizer has dexmedetomidine vials available. • Sandoz discontinued dexmedetomidine vials in April 2020. • Sun Pharma is no longer manufacturing dexmedetomidine. • Teva discontinued dexmedetomidine vials in July 2019. • WG Critical Care has dexmedetomidine vials available.

Estimated Resupply Dates • Accord has dexmedetomidine 100 mcg/mL 2 mL vials on intermittent back order and the

company is releasing product as it becomes available. • AuroMedics has dexmedetomidine 100 mcg/mL 2 mL vials on intermittent back order and the

company is releasing product as it becomes available. • Fresenius Kabi has dexmedetomidine 100 mcg/mL 2 mL vials on back order and the company

estimates a release date of late-May 2020. • Hikma has dexmedetomidine 100 mcg/mL 2 mL vials on back order and the company estimates

a release date of early-May 2020. • Mylan Institutional has dexmedetomidine 100 mcg/mL 2 mL vials on back order and the

company estimates a release date of mid- to late-May 2020. • Par has dexmedetomidine 100 mcg/mL 2 mL vials on intermittent back order and the company

is releasing product as it becomes available. • WG Critical Care has dexmedetomidine 100 mcg/mL 2 mL vials on allocation.


• Pfizer has Precedex 100 mcg/mL 2 mL vials available in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=491 Clindamycin Phosphate Injection May 7, 2020 Reason for the Shortage

• Alvogen injectable generic products including clindamycin are being marketed under the brand, Almaject Inc., as of October 1, 2019. The NDC numbers for these products have changed.

• Akorn discontinued clindamycin injection in early 2020. • Baxter has clindamycin injection on shortage due to manufacturing delays. • Fresenius Kabi did not provide a reason for the shortage. • Pfizer did not provide a reason for the shortages. Pfizer discontinued Cleocin premixed bags in

2018. • Sagent did not provide a reason for the shortage. • Sandoz did not provide a reason for the shortage.

Estimated Resupply Dates • Baxter has all clindamycin phosphate injection presentations on back order and the company

estimates a release date of mid-May 2020. • Pfizer has Cleocin 150 mg/mL 2 mL, 4 mL, and 6 mL ADD-Vantage vials on back order and the

company estimates a release date of February 2023. Clindamycin 150 mg/mL 2 mL and 4 mL vials are available in limited supply. The 150 mg/mL 6 mL vials are on back order and the company estimates a release date of May 2020.

• Sagent has clindamycin phosphate 150 mg/mL 2 mL and 4 mL vials on back order and the company estimates a release date of June 2020. The 6 mL vials are on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=97 Amino Acid Products May 7, 2020 Reason for the Shortage

• Baxter had Prosol on back order due to increased demand. • BBraun did not provide a reason for the shortage. • ICU Medical has Aminosyn presentations available.

Estimated Resupply Dates • BBraun has all amino acid presentations on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=564 Lorazepam Injection May 8, 2020 Reason for the Shortage

• Bedford discontinued lorazepam injection in May, 2011.[1] • Hikma has product on shortage due to manufacturing delays.[2] • Pfizer has product on shortage due to increased demand and manufacturing delays. Pfizer

discontinued 4 mg/mL 10 mL vials in December 2017.[3] • Akorn did not provide a reason for the shortage.[4] • Amphastar has product available.[5]



• Akorn has lorazepam 2 mg/mL 1 mL vials on back order and the company estimates a release date of mid-May 2020.[4]

• Hikma has lorazepam 4 mg/mL 1 mL and 10 mL vials on back order and the company estimates a release date of late-June to early-July 2020. The 2 mg/mL 1 mL and 10 mL vials are on back order and the company estimates a release date of mid-May 2020 for the 1 mL vials and late-May 2020 for the 10 mL vials.[2]

• Hikma has Ativan 2 mg/mL 10 mL vials and 4 mg/mL 10 mL vials on back order and the company estimates a release date of late-June to early-July 2020.[2]

• Pfizer has lorazepam 4 mg/mL 1 mL Carpuject syringes on back order and the company estimates a release date of January 2021. The 2 mg/mL 10 mL vials and 4 mg/mL 1 mL vials are on back order and the company estimates a release date of February 2021.[3]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=87 Leucovorin Calcium Injection May 8, 2020 Reason for the Shortage

• Fresenius Kabi has leucovorin on shortage due to manufacturing delays and increased demand. • Hikma did not provide a reason for the current shortage. • Mylan did not provide a reason for the current shortage. • Sagent has leucovorin on shortage due to manufacturing delays. • Teva has leucovorin available.

Estimated Resupply Dates • Fresenius Kabi has leucovorin 500 mg on back order and the company estimates a release date

of mid- to late-May 2020. The 10 mg/mL 50 mL vials are on back order and the company estimates a release date of late-July 2020.

• Hikma has leucovorin 350 mg vials on back order and the company estimates a release date of late-May 2020.

• Sagent has leucovorin 50 mg, 100 mg, 200 mg, 350 mg, and 500 mg vials on back order and the company estimates a release date of December 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=35 Hydrocortisone Oral Tablets May 8, 2020 Reason for the Shortage

• Amneal has hydrocortisone 20 mg tablets available. Amneal discontinued hydrocortisone 5 mg and 10 mg tablets in the first half of 2020.

• Greenstone did not provide a reason for the shortage. • Pfizer states the shortage is due to increase demand.

Estimated Resupply Dates • Amneal has discontinued hydrocortisone 10 mg tablets. The company is distributing supplies

until they are depleted. • Greenstone has hydrocortisone 5 mg, 10 mg, and 20 mg tablets in limited supply and the

company is allocating supplies. • Pfizer has Cortef 10 mg tablets in 100 count bottles on back order and the company estimates a

release date in late-May 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=648


Epinephrine Auto-Injectors May 8, 2020 Reason for the Shortage

• Amneal has discontinued Adrenaclick. Amneal acquired Impax in 2018. • Mylan has epinephrine auto-injectors available. • Sandoz did not provide a reason for the shortage. • Teva did not provide a reason for the shortage.

Estimated Resupply Dates • Amneal has epinephrine 0.15 mg/0.15 mL and 0.3 mg/0.3 mL auto-injectors on allocation. • Sandoz has Symjepi available with short expiration dating (November 2020 and March 2021). • Teva has epinephrine 0.15 mg/0.15 mL and 0.3 mg/0.3 mL auto-injectors on back order and the

company estimates release dates in early-June 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=420 Dibucaine Ointment May 8, 2020 Reason for the Shortage

• Perrigo discontinued dibucaine ointment 1% due to a raw ingredient shortage. • Rugby did not provide a reason for the shortage.

Estimated Resupply Dates • Rugby has dibucaine ointment 1% on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=658 Cyclosporine Oral Solution May 8, 2020 Reason for the Shortage

• Teva has cyclosporine oral solution on shortage due to an active pharmaceutical ingredient delay.

• Novartis has Neoral and SandImmune oral solutions available. Estimated Resupply Dates

• Teva has cyclosporine modified oral solution (NDC 00172-7313-20) on intermittent back order and the company is releasing supplies as they become available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=596 Cisatracurium Besylate Injection May 8, 2020 Reason for the Shortage

• Fresenius Kabi has cisatracurium on shortage due to increased demand. • Meitheal Pharmaceuticals has cisatracurium on shortage due to increased demand. • Pfizer has cisatracurium on shortage due to increased demand. • Sandoz has cisatracurium on shortage due to increased demand. • Somerset has cisatracurium on shortage due to increased demand. • Teva has cisatracurium on shortage due to increased demand. • AbbVie did not provide a reason for the shortage of Nimbex.



• Fresenius Kabi has cisatracurium 2 mg/mL 5 mL and 10 mL vials on back order and the company estimates a release date of early-June 2020 for the 5 mL vials and mid-May 2020 for the 10 mL vials. The 10 mg/mL 20 mL vials are on back order and the company estimates a release date of mid- to late-May 2020. Check wholesalers for inventory.

• Meitheal has all cisatracurium presentations on back order and the company estimates a release date of May 2020.

• Pfizer has cisatracurium 10 mg/mL 20 mL vials on back order and the company estimates a release date of July 2020. The 2 mg/mL 5 mL and 10 mL vials are on back order and the company estimates a release date of October 2020 for the 5 mL vials and July 2020 for the 10 mL vials.

• Sandoz has all cisatracurium presentations on allocation. • Somerset has all cisatracurium presentations on intermittent back order and the company is

releasing product as it becomes available. • Teva has all cisatracurium presentations on allocation. • AbbVie has Nimbex 10 mg/mL 20 mL vials available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=652 Trace Elements Injection May 11, 2020 Reason for the Shortage

• American Regent did not provide a reason for the shortage. They discontinued Multitrace-4 Concentrate 10 mL vials and regular 10 mL vials.

Estimated Resupply Dates American Regent has Multitrace-4 Concentrate 1 mL vials on back order and the company cannot estimate a release date. Multitrace-5 Concentrate 10 mL vials and regular 10 mL vials are on back order and the company cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=654 Pantoprazole Injection May 11, 2020 Reason for the Shortage

• AuroMedics had pantoprazole injection on shortage due to increased demand. • Hikma did not provide a reason for the shortage. • Pfizer had Protonix injection on shortage due to manufacturing delays.

Estimated Resupply Dates • AuroMedics has pantoprazole 40 mg vials on intermittent back order and the company is

releasing product as it becomes available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=550 Ondansetron Injection May 11, 2020 Reason for the Shortage

• Apotex has ondansetron injection available. • Athenex had ondansetron injection on shortage due to increased demand. • AuroMedics did not provide a reason for the shortage. • Fresenius Kabi did not provide a reason for the shortage.


• Heritage had ondansetron on shortage due to increased demand. Heritage discontinued ondansetron 2 mg/mL 2 mL vials in 10 count in late-2018.

• Hikma did not provide a reason for the shortage. • Mylan Institutional did not provide a reason for the shortage. • Pfizer has ondansetron injection on shortage due to manufacturing delays. The iSecure syringes

were discontinued in January 2020. • Sagent has ondansetron injection available. • Novartis discontinued Zofran 20 mL vials in May 2018.

Estimated Resupply Dates • Athenex has ondansetron 2 mg/mL 2 mL vials on back order and the company estimates a

release date of May 2020. • AuroMedics has ondansetron 2 mg/mL 2 mL vials on intermittent back order and the company is

releasing supplies as they become available. • Hikma has ondansetron 2 mg/mL 2 mL vials on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=405 Norepinephrine Bitartrate Injection May 11, 2020 Reason for the Shortage

• Baxter has norepinephrine injection available. • Hikma did not provide a reason for the shortage. • Mylan Institutional did not provide a reason for the shortage. • Pfizer had Levophed vials on shortage due to manufacturing delays. The ampules were

discontinued in December 2019. • Teva had norepinephrine injection on allocation due to increased demand.

Estimated Resupply Dates • Hikma has short-dated norepinephrine 1 mg/mL 4 mL vials available with an expiration date of

October 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=292 Methotrexate Injection May 11, 2020 Reason for the Shortage

• Accord has methotrexate injection on back order due to increased demand.[1] • Fresenius Kabi has methotrexate injection available.[2] • Mylan Institutional has methotrexate injection available.[3] • Pfizer has methotrexate injection available.[4] • Teva has methotrexate injection available.[5] • Hikma has methotrexate injection available.[6]

Estimated Resupply Dates • Fresenius Kabi has methotrexate 25 mg/mL 10 mL vials on back order and the company

estimates a release date of mid-May 2020.[2] https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=282


Heparin Injection May 11, 2020 Reason for the Shortage

• Fresenius Kabi has heparin injection available. • Hikma did not provide a reason for the shortage. • Mylan has heparin injection available. • Pfizer has heparin on shortage due to manufacturing delays. • Sagent has heparin on shortage due to manufacturing issues and increased demand.

Estimated Resupply Dates • Hikma has short-dated 1,000 unit/mL 30 mL vials available with an expiration date of February

2021. There are short-dated 5,000 unit/mL 1 mL syringes and 10 mL vials available with an expiration date of January 2021. The 1,000 unit/mL 2 mL vials are on back order and the company estimates a release date of mid- to late-May 2020. The 5,000 unit/mL 2 mL vials are on back order and the company estimates a release date of late-May 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=353 Disulfiram Tablets May 11, 2020 Reason for the Shortage

• Alvogen has the product on shortage due to shipping delays. • TEVA did not provide a reason for the shortage. • Mylan discontinued disulfiram tablets. • Rising Pharmaceuticals discontinued disulfiram tablets.

Estimated Resupply Dates • Alvogen has disulfiram 250 mg tablets on back order and the company estimates a release date

of late-May 2020. • Teva has disulfiram 250 mg and 500 mg tablets on back order and the company cannot estimate

a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=601 Bupivacaine and Epinephrine Injection May 11, 2020 Reason for the Shortage

• Fresenius Kabi has bupivacaine and epinephrine on shortage due to increased demand and manufacturing delays.

• Pfizer has bupivacaine with epinephrine on shortage due to manufacturing delays. Estimated Resupply Dates

• Fresenius Kabi has 0.25% Sensorcaine-MPF with epinephrine 10 mL vials on back order and the company estimates a release date of early- to mid-June 2020. The 0.25% Sensorcaine-MPF with epinephrine 30 mL vials are on back order and the company estimates a release date of mid-May 2020. The 0.25% Sensorcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of mid-May 2020. The 0.5% Sensorcaine-MPF with epinephrine 10 mL vials are on back order and the company estimates a release date of early-June 2020. The 0.5% Sensorcaine-MPF with epinephrine 30 mL vials are on back order and the company estimates a release date of mid-May 2020. The 0.5% Sensorcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of mid-May 2020. The


0.5% Sensorcaine-MPF with epinephrine 30 mL sterile packs are on back order and the company cannot estimate a release date.

• Pfizer has 0.25% bupivacaine with epinephrine 10 mL preservative-free vials on back order and the company estimates a release date of June 2021. The 0.25% bupivacaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of June 2021. The 0.25% bupivacaine with epinephrine 50 mL vials are on back order and the company estimates a release date of June 2021. The 0.5% bupivacaine with epinephrine 10 mL preservative-free vials are on back order and the company estimates a release date of June 2021. The 0.5% bupivacaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of June 2021.The 0.5% bupivacaine with epinephrine 50 mL vials are on back order and the company estimates a release date of June 2021.

• Pfizer has 0.25% Marcaine with epinephrine 10 mL preservative-free vials on back order and the company estimates a release date of June 2021. The 0.25% Marcaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of June 2021. The 0.25% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of June 2021. The 0.5% Marcaine with epinephrine 10 mL preservative-free vials are on back order and the company estimates a release date of June 2021. The 0.5% Marcaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of June 2021. The 0.5% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of June 2021.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=261 Midazolam Injection May 12, 2020 Reason for the Shortage

• Akorn has midazolam injection on shortage due to increased demand. • Athenex has midazolam injection on shortage due to increased demand. • Avet has midazolam injection on shortage due to increased demand. • Fresenius Kabi has midazolam injection on shortage due to increased demand. They are not

marketing the 5 mg/mL 5 mL vials and 5 mg/mL 2 mL syringes. • Hikma did not provide a reason for the shortage. • Pfizer has midazolam injection on shortage due to manufacturing delays and increased demand.

Estimated Resupply Dates • Akorn has 5 mg/mL 10 mL vials on back order and the company estimates a release date of mid-

May 2020. • Athenex has midazolam 1 mg/mL 2 mL vials on back order and the company cannot estimate a

release date. • Avet has midazolam 1 mg/mL 2 mL vials on allocation. The 5 mg/mL 5 mL and 10 mL vials are on

back order and the company estimates a release date of June 2020 for the 5 mL vials and July 2020 for the 10 mL vials.

• Fresenius Kabi has midazolam 5 mg/mL 10 mL vials and 1 mg/mL 5 mL vials on back order and the company estimates a release date of late-May 2020. The 5 mg/mL 1 mL vials are on back order and the company estimates a release date of late-June 2020. The 5 mg/mL 1 mL syringes are on back order and the company cannot estimate a release date. Check wholesalers for inventory.


• Hikma has midazolam 1 mg/mL 2 mL vials on allocation. The 1 mg/mL 5 mL vials are on back order and the company cannot estimate a release date. The 1 mg/mL 10 mL vials on back order and the company estimates a release date of mid- to late-May 2020. The 5 mg/mL 1 mL and 2 mL vials are on back order and the company estimates a release date of late-June to early-July 2020. The 5 mg/mL 10 mL vials are on allocation.

• Pfizer has midazolam 1 mg/mL 2 mL Carpuject syringes and 5 mg/mL 1 mL Carpuject syringes on back order and the company estimates a release date of June 2021. The 1 mg/mL 2 mL iSecure syringes are on back order and the company estimates a release date of February 2023. Midazolam 1 mg/mL 10 mL multi-dose vials are available in limited supply. The 5 mg/mL 1 mL and 2 mL preservative-free vials are available in limited supply. The 5 mg/mL 5 mL vials are on back order and the company estimates a release date of May 2020. The 5 mg/mL 10 mL vials are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=576 Fludarabine Injection May 12, 2020 Reason for the Shortage

• Fresenius Kabi did not provide a reason for the shortage. • Leucadia has fludarabine available. • Pfizer is discontinuing fludarabine in August 2020. Their estimated market share was less than

1%. • Sagent has fludarabine on shortage due to manufacturing delays. • Teva did not provide a reason for the shortage.

Estimated Resupply Dates • Pfizer has fludarabine lyophilized powder 50 mg vials available in limited supply. They are

discontinuing the product once it is depleted. • Sagent has fludarabine 25 mg/mL 2 mL vials on back order and the company estimates a release

date of June 2020. • Teva has fludarabine lyophilized powder 50 mg vials on back order and the company estimates a

release date of late-July 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=622 Fentanyl Citrate Injection May 12, 2020 Reason for the Shortage

• Akorn has fentanyl on shortage due to increased demand. • Fresenius Kabi on shortage due to increased demand. • Hikma has fentanyl injection on shortage due to supply and demand issues. They are not

currently marketing fentanyl ampules, just vials. • Pfizer has fentanyl injection on shortage due to increased demand. The 20 mL ampules were

discontinued in September 2017. Estimated Resupply Dates

• Akorn has fentanyl 50 mcg/mL 2 mL ampules on back order and the company estimates a release date of mid-June 2020.


• Fresenius Kabi has fentanyl 50 mcg/mL 20 mL and 50 mL vials on back order and the company estimates a release date of mid- to late-May 2020. The 2 mL and 5 mL vials are on back order and the company estimates a release date of mid- to late-May 2020.

• Hikma has fentanyl 50 mcg/mL 2 mL, 5 mL, and 50 mL vials on allocation. The 20 mL vials are on back order and the company estimates a release date of late-May 2020.

• Pfizer has fentanyl 50 mcg/mL 20 mL and 50 mL vials on back order and the company estimates a release date of May 2020. The 5 mL and 10 mL vials are on back order and the company estimates a release date of May 2020 for the 5 mL vials and August 2020 for the 10 mL vials. The 2 mL vials and 5 mL ampules are available in limited supply. The 2 mL Carpuject syringes are on back order and the company estimates a release date of January 2023.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=315 Doxycycline Hyclate Injection May 12, 2020 Reason for the Shortage

• Mylan Institutional did not provide a reason for the shortage. • Zydus discontinued doxycycline injection in mid-2019. • Fresenius Kabi did not provide a reason for the shortage.

Estimated Resupply Dates • Fresenius Kabi has doxycycline 100 mg vials on back order and the company estimates a release

date of mid-May 2020. • Mylan Institutional has doxycycline 100 mg vials on back order and the company estimates a

release date of mid-May 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=559 Acyclovir Injection May 12, 2020 Reason for the Shortage

• AuroMedics did not provide a reason for the shortage. • Fresenius Kabi had acyclovir injection on shortage due to increased demand.

Estimated Resupply Dates • AuroMedics has acyclovir 50 mg/mL 20 mL vials on intermittent back order and the company is

releasing product as it becomes available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=590 Valsartan Tablets May 13, 2020 Reason for the Shortage

• Several drug products containing valsartan were recalled due to an unexpected impurity found in the active pharmaceutical ingredient manufactured by a third party. The impurity is N-nitrosodimethylamine (NDMA) and is classified as a probable human carcinogen. Additional information is available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm.

• Camber, Major, Solco, and Teva valsartan tablets were affected by the recall. Detailed information on the products is available at https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf.


• Major, Solco, and Teva discontinued valsartan tablets in July 2018. • Alembic, Aurobindo, Cadista, MacLeod’s, and Novartis are not affected by this recall. • Aurobindo, and MacLeod’s refuse to provide updated availability information. • Cadista did not provide a reason for the shortage. • Lupin is not actively marketing valsartan tablets. • Mylan did not provide a reason for the shortage. • Repackagers may have some presentations affected depending on the source supplier.

Estimated Resupply Dates • Alembic has valsartan tablets on intermittent back order and the company is releasing product

as it becomes available. • Cadista has valsartan tablets on back order and the company cannot estimate a release date. • Camber has valsartan tablets on temporary discontinuation and the company cannot estimate a

release date. • Mylan has valsartan 160 mg tablets on back order and the company estimates a release date in

mid-May 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=444 Valsartan and Hydrochlorothiazide Tablets May 13, 2020 Reason for the Shortage

• Several drug products containing valsartan were recalled due to an unexpected impurity found in the active pharmaceutical ingredient manufactured by a third party. The impurity is N-nitrosodimethylamine (NDMA) and is classified as a probable human carcinogen. Additional information is available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm.

• Solco and Teva valsartan/hydrochlorothiazide tablets were affected by the recall. Detailed information on the products is available at https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf.

• Solco and Teva discontinued valsartan/hydrochlorothiazide tablets in July 2018. • Aurobindo refused to provide updated availability information. • Lupin has valsartan/hydrochlorothiazide tablets on back order because they are holding and

testing product for impurities. • MacLeod’s refuses to provide updated availability information. • Repackagers may have some presentations affected depending on the source supplier.

Estimated Resupply Dates • Alembic has all valsartan/hydrochlorothiazide presentations on allocation. • Lupin has all valsartan/hydrochlorothiazide presentations on back order and the company

cannot estimate a release date. • Mylan has valsartan/hydrochlorothiazide 80 mg/12.5 mg tablets on back order and the company

estimates a release date in early-June 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=445


Methyldopa Tablets May 13, 2020 Reason for the Shortage

• Accord has methyldopa temporarily unavailable due to shortage of raw ingredient. • Mylan discontinued the unit-dose presentations in 2019. They did not provide a reason for the

shortage of the 100 count bottles. • Teva discontinued methyldopa tablets in 2018.

Estimated Resupply Dates • Accord has temporarily discontinued methyldopa presentations and the company cannot

estimate when product will return. • Mylan has methyldopa 250 mg and 500 mg tablets in 100 count bottles on back order and the

company cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=462 Iothalamate Meglumine Injection May 13, 2020 Reason for the Shortage

• Guerbet did not provide a reason for the shortage. • Guerbet has discontinued Conray 30% and 43%.

Estimated Resupply Dates • Guerbet has Conray 60% in 30 mL and 50 mL vials on back order and the company estimates

release dates in early-June 2020. The 150 mL bottles are on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=623 Iopamidol Injection May 13, 2020 Reason for the Shortage

• Bracco Diagnostics is the sole supplier of iopamidol and did not provide a reason for the shortage.

Estimated Resupply Dates • Bracco Diagnostics has Isovue-M 200 (iopamidol 41%) in 10 mL vials on back order and the

company cannot estimate a release date. Isovue-200 (iopamidol 41%) 50 mL and 200 mL vials and Isovue-250 (iopamidol 51%) 50 mL vials, 150 mL bottles, and 200 mL bottles are also on back order and the company cannot estimate release dates.

• Bracco Diagnostics has Isovue-300 (iopamidol 61%) in 30 mL vials, 75 mL bottles, and 150 mL bottles on back order and the company cannot estimate release dates. Isovue-300 imaging bulk packages in 200 mL bottles are also on back order and the company cannot estimate a release date.

• Bracco Diagnostics has Isovue-370 (iopamidol 76%) in 75 mL and 150 mL bottles on back order and the company cannot estimate release dates.



Carisoprodol Tablets May 13, 2020 Reason for the Shortage

• Cadista discontinued carisoprodol tablets. • Endo Pharmaceuticals discontinued carisoprodol tablets. • Mylan has Soma tablets available. • Rising discontinued carisoprodol tablets. • Sciegen has carisoprodol tablets available. • Teva did not provide a reason for the shortage.

Estimated Resupply Dates • All marketed presentations are available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=558 Anagrelide Hydrochlorothiazide Capsules May 13, 2020 Reason for the Shortage

• Shire (Takeda) did not provide a reason for the shortage. • Teva did not provide a reason for the shortage. • Torrent has discontinued anagrelide 1 mg capsules. Torrent is working on relaunching

anagrelide 0.5 mg capsules. Estimated Resupply Dates

• Takeda has Agrylin 0.5 mg capsules on allocation. • Teva has anagrelide 0.5 mg and 1 mg capsules on back order and the company estimates a

release date of early-June 2020. • Torrent has anagrelide 0.5 mg and 1 mg capsules on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=610 Ampicillin Sodium and Sulbactam Sodium Injection May 13, 2020 Reason for the Shortage

• AuroMedics has ampicillin sulbactam vials on back order due to increased demand and manufacturing delays.

• Fresenius Kabi is not currently marketing ampicillin sulbactam injection. • Meitheal Pharmaceuticals has ampicillin sulbactam available. • Mylan Institutional refuses to provide availability information • Pfizer has discontinued generic ampicillin sulbactam except for the 1.5 gram and 3 gram ADD-

Vantage vials. • Piramal Critical Care has ampicillin sulbactam available. • Sagent has ampicillin sulbactam vials on back order due to manufacturing delays and increased

demand. • Sandoz discontinued ampicillin sulbactam. • WG Critical Care states the shortage is due to increased demand.

Estimated Resupply Dates • AuroMedics has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on intermittent back

order and the company is releasing product as it becomes available.


• Hikma has ampicillin sulbactam 1.5 gram and 3 gram vials on back order and the company estimates a release date of late-June to early-July 2020.

• Pfizer has Unasyn 1.5 gram vials and 15 gram bulk vials available in limited supply. The 1.5 gram and 3 gram ADD-Vantage vials are on back order and the company estimates a release date of May 2020.

• Sagent has ampicillin sulbactam 1.5 gram vials and 15 gram bulk vials on back order and the company estimates a release date of June 2020. The 3 gram vials are on back order and the company estimates a release date of May 2020.

• WG Critical Care has ampicillin sulbactam 1.5 gram and 3 gram vials on allocation. The 15 gram bulk vials on long-term back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=159 Losartan and Hydrochlorothiazide Tablets May 14, 2020 Reason for the Shortage


• Alembic did not provide a reason for the shortage. • Aurobindo refused to provide updated availability information • Cadista did not provide a reason for the shortage. • Lupin did not provide a reason for the shortage. • Merck has Hyzaar available. • Rising discontinued all losartan and hydrochlorothiazide presentations. • Sandoz recalled one lot of losartan and hydrochlorothiazide 100 mg/25 mg tablets in 1000 count

bottles in November 2018 due to an impurity found in the active pharmaceutical ingredient. Additional information can be found at https://www.fda.gov/Safety/Recalls/ucm625492.htm.

• Sandoz discontinued all losartan and hydrochlorothiazide presentations. • Torrent recalled several lots of losartan and hydrochlorothiazide tablet presentations due to an

impurity found in the active pharmaceutical ingredient. Additional information can be found at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/updated-torrent-pharmaceuticals-limited-expands-voluntary-nationwide-recall-losartan-potassium.

• Torrent has losartan and hydrochlorothiazide tablets available in all presentations (from lots unaffected by the recall).

• Teva did not provide a reason for the shortage. Estimated Resupply Dates

• Alembic has losartan and hydrochlorothiazide tablets on allocation to contracted customers • Cadista has losartan and hydrochlorothiazide tablets on allocation. • Lupin has losartan and hydrochlorothiazide tablets on back order and the company cannot

estimate a release date. • Teva has losartan and hydrochlorothiazide presentations on intermittent back order and the

company is releasing product as it becomes available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=529


Dimercaprol Injection May 14, 2020 Reason for the Shortage

• Akorn has Bal in Oil on shortage due to regulatory delays. Estimated Resupply Dates

• Akorn has Bal in Oil 100 mg/mL 3 mL ampules on back order and the company estimates a release date of early-July 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=659 Calcium Chloride Injection May 14, 2020 Reason for the Shortage

• American Regent did not provide a reason for the shortage. • Amphastar has calcium chloride on shortage due to increased demand. • Medefil launched calcium chloride 10 mL syringes in early-November 2019. • Mylan Institutional has withdrawn calcium chloride syringes from the market. The company

recalled the syringes in April 2015 due to incompatibility of the syringes and some needless adaptors.

• Pfizer has calcium chloride on shortage due to manufacturing delays. Estimated Resupply Dates

• American Regent has calcium chloride 100 mg/mL 10 mL vials are available in limited supply. • Amphastar has calcium chloride 100 mg/mL 10 mL syringes on allocation. • Pfizer has calcium chloride 100 mg/mL 10 mL Ansyr syringes and 100 mg/mL 10 mL LifeShield

syringes available in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=48 Bumetanide Injection May 14, 2020 Reason for the Shortage

• Pfizer has bumetanide injection on shortage due to manufacturing delays. • Hikma has bumetanide injection available.

Estimated Resupply Dates • Hikma has bumetanide 0.25 mg/mL 4 mL vials and 10 mL vials on back order and the company

estimates a release date of late-June to early-July 2020. • Pfizer has bumetanide 0.25 mg/mL 10 mL vials on back order and the company estimates a

release date of September 2020. The 4 mL vials are available in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=307 Amiodarone Injection May 14, 2020 Reason for the Shortage

• Baxter had Nexterone premixed bags on shortage due to manufacturing delays. • Mylan Institutional did not provide a reason for the shortage. • Hikma did not provide a reason for the shortage; however, the 50 mg/mL, 3 mL 10 count

presentation was discontinued in December 2018. • Sagent discontinued amiodarone 50 mg/mL 3 mL syringes in June 2019.


• Bretylium injection is not affected by this shortage. Estimated Resupply Dates

• AuroMedics has amiodarone 50 mg/mL 3 mL, 9 mL, and 18 mL vials on long-term back order and the company cannot estimate a release date.

• Baxter has Nexterone 150 mg/100 mL and 360 mg/200 mL premixed bags on intermittent back order with regular releases.

• Fresenius Kabi has amiodarone 50 mg/mL 3 mL and 9 mL vials on back order and the company estimates a release date of late-May 2020 for the 3 mL vials and early- to mid-June 2020 for the 9 mL vials.

• Hikma has amiodarone 50 mg/mL 3 mL vials on back order and the company estimates a release date of early-June 2020.

• Mylan Institutional has amiodarone 50 mg/mL 3 mL vials on back order and the company estimates a release date of mid-June 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=374 Testosterone Cypionate Injection May 15, 2020 Reason for the Shortage

• Cipla did not provide a reason for the shortage. The 100 mg/mL 10 mL vials have been discontinued. The 200 mg/mL 1 mL and 10 mL vials have new NDC numbers.

• Hikma and Perrigo did not provide a reason for the shortage. • Pfizer did not provide a reason for the shortage of Depo-Testosterone. • Sun Pharma has testosterone cypionate injection available.

Estimated Resupply Dates • Cipla has testosterone cypionate 200 mg/mL 10 mL vials on back order and the company cannot

estimate a release date. • Hikma has testosterone cypionate 200 mg/mL 1 mL vials on back order and the company

estimates a release date of mid- to late-May 2020. The 10 mL vials are on allocation. • Perrigo has testosterone cypionate 200 mg/mL 1 mL vials on intermittent back order and the

company is releasing product as it becomes available. • Pfizer has testosterone cypionate 200 mg/mL 1 mL vials on back order and the company

estimates a release date of July 2020. • Sun has testosterone cypionate 200 mg/mL 1 mL and 10 mL vials, and 100 mg/mL 10 mL vials on

back order and the company cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=592 Sodium Phosphate Injection May 15, 2020 Reason for the Shortage

• American Regent is not currently marketing sodium phosphate injection.[1] • Fresenius Kabi has sodium phosphate injection available.[2] • Pfizer has sodium phosphate injection on shortage due to manufacturing delay.[3]

Estimated Resupply Dates • Fresenius Kabi has sodium phosphate 3 mmol/mL 5 mL and 15 mL vials on back order and the

company estimates a release date of early- to mid-June 2020 for the 5 mL vials and late-May 2020 for the 15 mL vials.[2]


• Pfizer has sodium phosphate 3 mmol/mL 15 mL vials on back order and the company estimates a release date of August 2020.[3]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=227 Nalbuphine Injection May 15, 2020 Reason for the Shortage

• Pfizer has nalbuphine on shortage due to manufacturing delays.[1] Estimated Resupply Dates

• Pfizer has nalbuphine 10 mg/mL 1 mL ampules and 20 mg/mL 1 mL ampules on back order and the company estimates a release date of December 2020. The 20 mg/mL 10 mL vials are on back order and the company estimates a release date of November 2020. The 10 mg/mL 10 mL vials are available in limited supply.[1]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=599 Mepivacaine Injection May 15, 2020 Reason for the Shortage

• Fresenius Kabi has Polocaine available. • Pfizer states the reason for the shortage is manufacturing delays.

Estimated Resupply Dates • Pfizer has 2% Carbocaine 20 mL preservative-free vials, 2% Carbocaine 50 mL multiple-dose

vials, 1% Carbocaine 30 mL preservative-free vials, and 1.5% Carbocaine 30 mL preservative-free vials on back order and the company estimates a release date of July 2021.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=331 Etomidate Injection May 15, 2020 Reason for the Shortage

• American Regent is not currently marketing etomidate. • Athenex did not provide a reason for the current shortage. • AuroMedics did not provide a reason for the current shortage. • Hikma did not provide a reason for the shortage. • Mylan Institutional has etomidate available. • Par Sterile Products discontinued etomidate in early 2015. • Pfizer has Amidate on shortage due to manufacturing delays. Pfizer discontinued etomidate

ampules in October 2016. • Sagent is no longer marketing etomidate. • Zydus did not provide a reason for the shortage.

Estimated Resupply Dates • Athenex has etomidate 2 mg/mL 10 mL and 20 mL vials on back order and the company cannot

estimate a release date. • AuroMedics has etomidate 2 mg/mL 10 mL and 20 mL vials on intermittent back order and the

company is releasing product as it becomes available.


• Hikma has etomidate 2 mg/mL 10 mL and 20 mL vials on back order and the company estimates a release date of late-June to early-July 2020 for the 10 mL vials and late-July 2020 for the 20 mL vials.

• Pfizer has Amidate 2 mg/mL 20 mL LifeShield syringes on back order and the company estimates a release date of February 2021.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=147 Enalaprilat Injection May 15, 2020 Reason for the Shortage

• Hikma has enalaprilat injection on shortage due to increased demand. • Pfizer has enalaprilat injection on shortage due to manufacturing delays.

Estimated Resupply Dates • Pfizer has enalaprilat 1.25 mg/mL 1 mL and 2 mL vials on back order and the company estimates

a release date of February 2021. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=488 Dobutamine Injection May 15, 2020 Reason for the Shortage

• Baxter has dobutamine available. • Pfizer has dobutamine on shortage due to manufacturing delays.

Estimated Resupply Dates • Pfizer has dobutamine 12.5 mg/mL 20 mL latex-free vials on back order with an estimated

release date of February 2023. The 12.5 mg/mL 20 mL fliptop vials in 10 count are on back order and the company estimates a release date of May 2020.

• Pfizer has dobutamine 4 mg/mL in 250 mL bags on back order and the company estimates a release date of September 2020. The 1 mg/mL 250 mL bags are on back order and the company estimates a release date of September 2020. The 2 mg/mL in 250 mL bags are on back order and the company estimates a release date of September 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=296 Bupivacaine Injection May 15, 2020 Reason for the Shortage

• AuroMedics has not provided a reason for the shortage. • Fresenius Kabi had Sensorcaine on shortage due to increased demand for the product. • Pfizer has bupivacaine on shortage due to manufacturing delays. Pfizer discontinued 0.5%

bupivacaine 30 mL glass ampules in December 2017. Estimated Resupply Dates

• Areva is temporarily importing 0.25% bupivacaine and 0.5% bupivacaine 5 mL and 10 mL ampules. FDA is allowing temporary importation of product from Italy manufactured by Areva's supplier, Fisiopharma. Details on how to obtain product and differences between the US and Italian labeling can be found at: http://arevapharma.com/wp-content/uploads/2019/09/Dear-Health-Care-Provider-Letter-final.pdf.


• AuroMedics has 0.5% bupivacaine 30 mL preservative-free vials on intermittent back order and the company is releasing product as it becomes available.

• Pfizer has 0.25% bupivacaine 10 mL preservative-free vials available in limited supply. • Pfizer has 0.25% Marcaine 10 mL preservative-free vials on back order and the company

estimates a release date of June 2020. The 0.25% 50 mL vials are on back order and the company estimates a release date of August 2020. The 0.5% Marcaine 30 mL preservative-free vials are on back order and the company estimates a release date of June 2020. The 0.5% 50 mL vials are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=172 Azithromycin Injection May 15, 2020 Reason for the Shortage

• Apotex has discontinued azithromycin injection. • AuroMedics did not provide a reason for the shortage. • Fresenius Kabi had azithromycin injection on shortage due to increased demand. • Pfizer has azithromycin injection on shortage due to manufacturing delays. • Slate Run Pharmaceuticals has seen increased demand. • Sun Pharma is not currently manufacturing azithromycin injection.

Estimated Resupply Dates • AuroMedics has azithromycin 500 mg vials on intermittent back order and the company is

releasing product as it becomes available. • Fresenius Kabi has azithromycin 500 mg vials on back order and the company estimates a

release date of late-May 2020. • Pfizer has azithromycin 500 mg ADD-Vantage vials on back order and the company estimates a

release date of October 2020. Zithromax 500 mg vials are on back order and the company estimates a release date of August 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=380 Venlafaxine Hydrochloride Extended-Release Capsules May 18, 2020 Reason for the Shortage

• Pfizer has Effexor XR capsules available. • Teva did not provide a reason for the shortage. • Zydus did not provide a reason for the shortage. Zydus has discontinued the 30 count

presentations. Estimated Resupply Dates

• Teva has all venlafaxine extended-release capsules on back order and the company estimates release dates in late-May 2020.

• Zydus has all venlafaxine extended-release capsules on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=587


Sertraline Oral Tablets May 18, 2020 Reason for the Shortage

• Accord did not provide a reason for the shortage. • Aurobindo refuses to provide availability information. • Cipla USA did not provide a reason for the shortage. • Exelan Pharmaceuticals did not provide a reason for the shortage. • Lupin did not provide a reason for the shortage.

Estimated Resupply Dates • Accord has sertraline 100 mg tablets in 500- and 90-count bottles and 50 mg tablets in 500-

count bottles on back order and the company estimates a release date of early-June 2020. • Cipla has sertraline 25 mg tablets in 30-, 90-, and 500-count bottles and 50 mg tablets in 30- and

500-count bottles on back order and the company estimates a release date of late-May 2020. The 100 mg tablets in 500-count bottles are on back order and the company estimates a release date of mid-June 2020. The 100 mg tablets in 30-count bottles are on back order and the company cannot estimate a release date.

• Exelan Pharmaceuticals has sertraline 50 mg tablets in 90- and 180-count bottles on back order and the company estimates a release date of May 2020.

• Lupin has sertraline 100 mg tablets in 30-, 90-, 500-, and 5,000-count bottles are on back order and the company estimates a release date of mid-June 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=660 Levetiracetam Extended-Release Tablets May 18, 2020 Reason for the Shortage

• Apotex did not provide a reason for the shortage. • Lupin did not provide a reason for the shortage. • OWP is discontinuing their Roweepra XR formulations. • Sun Pharma did not provide a reason for the shortage. • Torrent is not selling their levetiracetam extended-release tablets within the US.

Estimated Resupply Dates • Apotex has levetiracetam 500 mg and 750 mg extended-release tablets on allocation. • Lupin has levetiracetam 500 mg and 750 mg extended-release tablets on intermittent back

order and the company is releasing product as it becomes available. • Sun Pharma has levetiracetam 500 mg extended-release tablets on back order and the company

estimates a release date of mid-June 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=583 Vancomycin Hydrochloride Injection May 19, 2020 Reason for the Shortage

• Alvogen has vancomycin injection available.[1] • Athenex has vancomycin injection available.[2] • AuroMedics did not provide a reason for the shortage.[3] • Baxter has vancomycin injection available.[4] • Fresenius Kabi has vancomycin injection available.[5]


• Hikma did not provide a reason for the shortage.[6] • Mylan Institutional has vancomycin injection available.[7] • Pfizer has vancomycin vials on back order due to manufacturing delays.[8] • Samson Medical Technologies has vancomycin injection available.[9] • Sagent has vancomycin injection on shortage due to manufacturing delays.[10] • Xellia Pharmaceuticals has vancomycin injection and vancomycin premixed bags available.[11]

Estimated Resupply Dates • AuroMedics has vancomycin 1 gram vials on long-term back order and the company cannot

estimate a release date.[3] • Baxter has vancomycin 750 mg/150 mL 0.9% sodium chloride premixed bags available in limited

supply.[4] • Fresenius Kabi has vancomycin 500 mg and 750 mg vials on back order and the company

estimates a release date of late-May 2020 for the 500 mg vials and mid- to late-May 2020 for the 750 mg vials.[5]

• Hikma has vancomycin 750 mg vials on allocation. The 5 gram and 10 gram vials are on back order and the company estimates a release date of late-May 2020 for the 5 gram vials and early-August 2020 for the 10 gram vials.[6]

• Pfizer has vancomycin 500 mg ADD-Vantage vials on back order and the company estimates a release date of June 2020. The 500 mg regular vials are available in limited supply.[8]

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=25 Tacrolimus Capsules May 19, 2020 Reason for the Shortage

• Accord has tacrolimus on temporary discontinuation due to raw ingredient shortage. • Astellas has Prograf available. • Bionpharma did not provide a reason for the shortage. • Lannett has discontinued tacrolimus capsules. • Major did not provide a reason for the shortage. • Mylan has tacrolimus available. • Sandoz has tacrolimus on allocation.

Estimated Resupply Dates • Accord has temporarily discontinued tacrolimus 0.5 mg, 1 mg, and 5 mg capsules. • Bionpharma has tacrolimus 0.5 mg, 1 mg, and 5 mg capsules on back order and the company

cannot estimate a release date. • Major has tacrolimus 0.5 mg capsules on back order and the company estimates a release date

of early-June 2020. • Sandoz has tacrolimus 0.5 mg, 1 mg, and 5 mg capsules in 100 count on allocation. • Strides has tacrolimus 1 mg capsules on allocation.



Rocuronium Injection May 19, 2020 Reason for the Shortage

• Athenex did not provide a reason for the shortage. They are no longer marketing the 10 mL vials • AuroMedics did not provide a reason for the shortage. • Baxter has rocuronium available. • Fresenius Kabi did not provide a reason for the shortage. • Hikma did not provide a reason for the shortage. • Mylan Institutional did not provide a reason for the shortage. • Pfizer has rocuronium on shortage due to increased demand. • Sagent did not provide a reason for the shortage. • Sandoz did not provide a reason for the shortage. • X-Gen did not provide a reason for the shortage.

Estimated Resupply Dates • Athenex has rocuronium 10 mg/mL 5 mL vials on back order and the company estimates a

release date of May 2020. • AuroMedics has rocuronium 10 mg/mL 5 mL and 10 mL vials on intermittent back order and the

company is releasing product as it becomes available. • Fresenius Kabi has rocuronium 10 mg/mL 5 mL vials on back order and the company estimates a

release date of May 2020. • Hikma has rocuronium 10 mg/mL 5 mL and 10 mL vials on back order and the company

estimates a release date of early-June 2020. • Mylan Institutional has rocuronium 10 mg/mL 10 mL vials on back order and the company

cannot estimate a release date. • Pfizer has rocuronium 10 mg/mL 5 mL and 10 mL vials available in limited supply. • Sagent has rocuronium 10 mg/mL 5 mL and 10 mL vials on back order and the company

estimates a release date of July 2020. • Sandoz has rocuronium 10 mg/mL 5 mL and 10 mL vials on allocation. • X-Gen has rocuronium 10 mg/mL 5 mL and 10 mL vials on back order and the company cannot

estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=290 Nitroglycerin Injection May 19, 2020 Reason for the Shortage

• American Regent did not provide a reason for the shortage. • Nitroglycerin premixed bags are not affected by this shortage.

Estimated Resupply Dates • American Regent has nitroglycerin 5 mg/mL 10 mL vials on back order and the company cannot

estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=626


Lorazepam Tablets May 19, 2020 Reason for the Shortage

• Aurobindo refuses to provide availability information. • Bausch Health did not provide a reason for the shortage. • Leading has lorazepam tablet presentations available. • Major had lorazepam tablets on shortage due to increased demand. • Mylan has discontinued all bottled presentations. • Mylan Institutional discontinued all unit-dose blister pack presentations. • Sandoz discontinued all lorazepam presentations. • Teva did not provide a reason for the shortage.

Estimated Resupply Dates • Bausch Health has Ativan 1 mg tablets on back order and the company cannot estimate a

release date. Ativan 0.5 mg tablets in 100 count bottles and 2 mg tablets in 100 count bottles are available with short expiration dating of January 2021.

• Teva has lorazepam 2 mg tablets in 1,000 count bottles on back order and the company estimates a release date of May 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=480 Lidocaine with Epinephrine Injection May 19, 2020 Reason for the Shortage

• Fresenius Kabi has Xylocaine with epinephrine presentations on shortage due to increased demand for the product and manufacturing delays.

• Pfizer has lidocaine with epinephrine presentations on shortage due to manufacturing delays. Estimated Resupply Dates

• Fresenius Kabi has 1% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials on back order and the company estimates a release date of mid- to late-May 2020. The 1% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials in sterile packs are on back order and the company cannot estimate a release date. The 1.5% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials in sterile packs are on back order and the company cannot estimate a release date. The 2% Xylocaine-MPF with epinephrine (1:200,000) 20 mL vials are on back order and the company estimates a release date of late-May 2020. The 2% Xylocaine-MPF with epinephrine (1:200,000) 20 mL vials in sterile packs are on back order and the company cannot estimate a release date. Check wholesalers for inventory.

• Pfizer has 1.5% lidocaine with epinephrine (1:200,000) 30 mL vials available in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=98 Aminophylline Injection May 19, 2020 Reason for the Shortage

• Pfizer had aminophylline injection on shortage due to manufacturing delays. Estimated Resupply Dates

• Pfizer has aminophylline 25 mg/mL 10 mL and 20 mL vials available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=407


23.4% Sodium Chloride Injection May 19, 2020 Reason for the Shortage

• Fresenius Kabi has 23.4% sodium chloride injection available. • Pfizer has 23.4% sodium chloride injection on shortage due to increased demand.

Estimated Resupply Dates • Fresenius Kabi has 23.4% sodium chloride vials on back order. • The 30 mL (NDC 63323-0187-30) vials have an estimated release date of late-June to early-July

2020. • The 100 mL (NDC 63323-0088-61) vials have an estimated release date of late-June 2020. • The 200 mL (NDC 63323-0088-63) vials have an estimated release date of mid- to late-May

2020. • Pfizer has 23.4% sodium chloride 100 mL vials (NDC 00409-1141-02) on back order with an

estimated release date of September 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=336 Tobramycin Sulfate Lyophilized Powder for Solution May 20, 2020 Reason for the Shortage

• Fresenius Kabi has tobramycin lyophilized powder on shortage due to increased demand. • X-Gen did not provide a reason for the shortage.

Estimated Resupply Dates • Fresenius Kabi has tobramycin 1.2 gram vials on back order and the company estimates a

release date of late-May 2020. Check wholesalers for inventory. • X-Gen has tobramycin 1.2 gram vials on back order and the company estimates a release date of

early- to mid-June 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=649 Propofol Emulsion Injection May 20, 2020 Reason for the Shortage

• Dr. Reddy's has propofol on shortage due to increased demand.[1] • Fresenius Kabi has Diprivan available but may experience intermittent back order due to

increased demand. Check wholesaler for inventory.[2] • Pfizer has propofol on shortage due to increased demand.[3] • Sagent has propofol on shortage due to increased demand.[4] • Teva has propofol on shortage due to shipping delays related to COVID-19.[5]

Estimated Resupply Dates • Dr. Reddy has propofol 20 mL, 50 mL, and 100 mL vials available in limited supply. The next

estimated release date is October 2020.[1] • Pfizer has propofol 20 mL, 50 mL, and 100 mL vials available in limited supply for direct

shipment only.[3] • Sagent has propofol 20 mL, 50 mL, and 100 mL vials on allocation.[4] • Teva has propofol 20 mL, 50 mL, and 100 mL vials on intermittent back order and the company

is allocating upon release. [5] https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=651


Heparin Sodium Premixed Bags May 20, 2020 Reason for the Shortage

• Baxter has heparin premix available. • BBraun has heparin premixes available. • Fresenius Kabi had put heparin on a protective allocation due to a potential shortage of raw

ingredient. The letter describing this in detail is available at the following link: https://www.fresenius-kabi.com/us/news/fresenius-kabi-responds-to-a-potential-shortage-of-heparin.

• Pfizer has heparin on shortage due to manufacturing delays. Estimated Resupply Dates

• Fresenius Kabi has heparin 25,000 units/250 mL in 5% dextrose premixed bags and 25,000 units/500 mL in 5% dextrose premixed bags on back order and the company estimates a release date of early- to mid-June 2020. There are short-dated 25,000 units/500 mL in 0.45% sodium chloride premixed bags available with an expiration date of <6 months.

• Pfizer has heparin 25,000 units/250 mL in 5% dextrose premixed bags on back order and the company estimates a release date of September 2020. The 200 units/100 mL in 0.9% sodium chloride premixed bags are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=468 *Please refer to ASHP website for more information at: https://www.ashp.org/Drug-Shortages/Current-Shortages

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