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Drug Information Update June 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 .............................. 8

STUDIES AND RECENT TOPICS ............................................................... 19

RECALLS ................................................................................................ 25

CURRENT DRUG SHORTAGES ................................................................ 33


NEWLY AVAILABLE GENERICS

GENERIC DRUG NAME STRENGTH & DOSAGE FORM

GENERIC MANUFACTURER BRAND NAME

FLUORIDE (SODIUM) 1.1 % PASTE COLGATE ORAL PH PREVIDENT

SODIUM FLUORIDE/ POTASSIUM NIT 1.1 %-5 % PASTE SHEFFIELD PHARM SODIUM FLUORIDE

SENSITIVE

DESONIDE 0.05 % GEL CINTEX SERVICES LEO PHARMA INC. DESONATE


NEW DRUG ENTITIES/STRENGTHS/COMBINATIONS

DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES

HEP C VIRUS, NUCLEOTIDE

ANALOG NS5B POLYMERASE INH

SOVALDI SOFOSBUVIR

150 MG, 200 MG

ORAL PELLETS, PACKET

NEW DOSAGE FORM AND STRENGTH

HEP C VIRUS-NS5B POLYMERASE AND

NS5A INHIB. COMBO.

HARVONI LEDIPASVIR/ SOFOSBUVIR

45 MG-200 MG, 33.75 MG-150 MG

ORAL PELLETS, PACKET


ANTI-INFLAMMATORY

TUMOR NECROSIS FACTOR INHIBITOR

AVSOLA INFLIXIMAB-AXXQ 100 MG IV SOLUTION, VIAL

BIOSIMILAR TO REMICADE

ANTIHYPERLIPIDEMIC-ACLY AND

CHOLES ABSORP INHIB

NEXLIZET BEMPEDOIC ACID/EZETIMIBE

180 MG-10 MG ORAL TABLET NEW COMBINATION

AGENTS TO TREAT MULTIPLE SCLEROSIS

ZEPOSIA OZANIMOD HYDROCHLORIDE

0.92 MG ORAL CAPSULE NEW ENTITY

AGENTS TO TREAT MULTIPLE SCLEROSIS

ZEPOSIA OZANIMOD HYDROCHLORIDE

0.23 MG (4)-0.46 MG (3); 0.23 MG (4)-0.46 MG (3)-

0.92 MG (30) ORAL CAPSULES,

DOSE PACK

NEW ENTITY

TOPICAL ANTI-INFLAMMATORY,

NSAIDS DICLOVIX M DICLOFENAC/

MENTHOL/TAPE 1.5 %-8 %

TOPICAL KIT RX +OTC

CONTRACEPTIVES, INTRAVAGINAL PHEXXI

LACTIC ACID/CITRIC/ POTASSIUM

1.8 %-1 %-0.4 % VAGINAL GEL NEW COMBINATION

LHRH (GNRH) ANTAGONIST,

ESTROGEN AND PROGESTIN COMB

ORIAHNN ELAGOLIX/

ESTRADIOL/ NORETHINDRN

300 MG-1 MG-0.5 MG (AM)/300 MG

(PM) ORAL CAPSULES

NEW COMBINATION


DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES

ANTIPARKINSON-ISM DRUGS, OTHER KYNMOBI APOMORPHINE

HCL

10 MG, 15 MG, 20 MG, 25 MG, 30

MG SUBLINGUAL FILM

NEW ROUTE, DOSAGE FORM, AND STRENGTH

TOPICAL ANTIBIOTICS ZILXI MINOCYCLINE HCL 1.5 % TOPICAL

FOAM NEW STRENGTH

ANTIVIRALS,HIV-1 INTEGRASE

STRAND TRANSFER INHIBTR

TIVICAY PD DOLUTEGRAVIR SODIUM

5 MG ORAL TABLET FOR SUSPENSION


INSULINS LYUMJEV INSULIN LISPRO-AABC

100 UNIT/ML INJECTION

SOLUTION, VIAL NEW FORMULATION

INSULINS LYUMJEV

KWIKPEN U-100

INSULIN LISPRO-AABC


SOLUTION, PEN NEW FORMULATION

INSULINS LYUMJEV

KWIKPEN U-200

INSULIN LISPRO-AABC


SOLUTION, PEN NEW FORMULATION


NEW INDICATIONS (EXISTING DRUGS)

POMALYST

May 15, 2020

PRINCETON, N.J.- Bristol Myers Squibb (NYSE: BMY) today announced that Pomalyst ® (pomalidomide) was approved by the U.S. Food and Drug Administration (FDA) for patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy (HAART), or in patients with Kaposi sarcoma who are HIV-negative.3 Patients with AIDS-related Kaposi sarcoma should continue HAART for their HIV as recommended by their physician. Pomalyst was granted accelerated approval, Breakthrough Therapy designation and Orphan Drug designation in these indications based on overall response rates observed in a Phase 1/2 open label, single-arm clinical trial (12-C-0047). Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial. Source: Bristol Myers Squibb

RUBRACA

May 15, 2020

BOULDER, Colo.- Clovis Oncology, Inc. (NASDAQ: CLVS), announced today that the U.S. Food and Drug Administration (FDA) approved Rubraca® (rucaparib) tablets for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. The FDA approved this indication under accelerated approval based on objective response rate (ORR) and duration of response (DOR) data from the multi-center, single arm TRITON2 clinical trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The TRITON3 clinical trial is expected to serve as the confirmatory study for the Rubraca accelerated approval in mCRPC. Warning and precautions include myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) and embryo-fetal toxicity. Source: Clovis Oncology, Inc.

TECENTRIQ

May 19, 2020

Basel– Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) as a first-line (initial) treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression (PD-L1 stained ≥ 50% of tumour cells [TC ≥ 50%] or PD-L1 stained tumour-infiltrating [IC] covering ≥ 10% of the tumour area [IC ≥ 10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumour aberrations. Source: Roche

LYNPARZA

May 20, 2020


AstraZeneca and Merck & Co., INc., Kenilworth,NJ, US- Merck: known as MSD outside the US and Canada) today announced that LYNPARZA® (olaparib) has been approved in the US for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Patients will be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA. Source: AstraZeneca and Merck & Co.

FERRIPROX

May 21, 2020

Boston-Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), today announced that the U.S. Food and Drug Administration (FDA) has approved Ferriprox® (deferiprone) twice-a-day tablets for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate1. The new formulation of twice-a-day Ferriprox 1000 mg oral tablets eliminates the mid-day dose. Source: Chiesi Group

OPDIVO + YERVOY

May 26, 2020

Princeton, NJ- Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 360 mg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) given with two cycles of platinum-doublet chemotherapy was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.1 The therapy is approved for patients with squamous or non-squamous disease and regardless of PD-L1 expression.1 This application was reviewed under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.2 On May 15, the FDA approved Opdivo + Yervoy as a first-line treatment for certain patients with metastatic NSCLC whose tumors express PD-L1≥1% as determined by an FDA-approved test. Source: Bristol Myers Squibb

DUPIXENT

May 26, 2020

Paris and Tarrytown, NY- The U.S. Food and Drug Administration (FDA) approved Dupixent ® (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent is the only biologic medicine approved for this patient population. Source. Sanofi


OPDIVO

June 10, 2020

PRINCETON, N.J-Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo ® (nivolumab) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.1 This application was granted Priority Review Designation by the FDA, and the approval is based on the Phase 3 ATTRACTION-3 trial in which Opdivo (n=210) demonstrated superior overall survival (OS) versus taxane chemotherapy (n=209) (investigator’s choice of docetaxel or paclitaxel) (hazard ratio [HR] 0.77; 95% confidence interval [CI]: 0.62 to 0.96; p=0.0189).1,2 The median OS was 10.9 months (95% CI: 9.2 to 13.3) for Opdivo compared to 8.4 months (95% CI: 7.2 to 9.9) for docetaxel or paclitaxel.1 Opdivo is the first approved immunotherapy in this setting regardless of tumor PD-L1 expression level. Source: Bristol Myers Squibb

RECARBIO KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for RECARBRIO™ (imipenem, cilastatin, and relebactam) for the treatment of patients 18 years of age and older with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following susceptible Gram-negative microorganisms: Acinetobacter calcoaceticus-baumanniicomplex, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Pseudomonas aeruginosa and Serratia marcescens. To reduce the development of drug-resistant bacteria and maintain the effectiveness of RECARBRIO and other antibacterial drugs, RECARBRIO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. RECARBRIO is contraindicated in patients with a history of known severe hypersensitivity to any component of RECARBRIO. See Selected Safety Information below. Source: Merck


FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS

Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid (Thyroid Tablets, USP) Due to Super Potency

[Posted May 22, 2020]

Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® (thyroid tablets, USP) to the consumer level. The products are being recalled because our testing has found these lots to be superpotent. The product may have up to 115.0% of the labeled amount of Liothyronine (T3).

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive superpotent NP Thyroid, may experience signs and symptoms of hyperthyroidism (overactive thyroid) which include, but are not limited to, weight loss, heat intolerance, fatigue, muscle weakness, hypertension, chest pain, rapid heart rate, or heart rhythm disturbances. Pregnant women who take superpotent NP Thyroid may also experience negative maternal and fetal outcomes including miscarriage and/or impairment to fetal development. Patients should talk to their healthcare professional before they stop taking their NP Thyroid medicine. To date, Acella has received two reports of adverse events known to be related to this recall.

NP Thyroid (thyroid tablets, USP) is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid). The products subject to recall are packed in 100-count bottles. See product images.

To best identify the product, the NDC’s, Product Description, Lot Numbers and Expiration Dates are listed. These lots were distributed nationwide in the USA to Acella’s direct accounts.

NDC Description Lot Expiration Date

41292-329-01 NP Thyroid 30mg M329A19-1 M329H18-1 M329J18-1 M329J18-2 M329J18-3 M329M18-2

12/2020 07/2020 08/2020 08/2020 08/2020 08/2020

42192-330-01 NP Thyroid 60mg M330J18-2A M330J18-3

08/2020 08/2020

42192-331-01 NP Thyroid 90mg M331G18-1 M331J18-1 M331J18-2 M331M18-1 M331M18-2

07/2020 08/2020 08/2020 11/2020 11/2020


Acella is proactively notifying its wholesalers by email and phone to discontinue distribution of the product being recalled and is arranging for return of all recalled products. Patients who are currently taking NP Thyroid from the lots being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.

Consumers with questions about the recall can email Acella Pharmaceuticals at [email protected] or contact Acella Customer Service at 1-800-541-4802, Monday through Thursday from 9:00 am to 5:00 pm ET and Friday from 9:00 am to 12:30 pm ET. 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)

Apotex Corp. Issues Voluntary Nationtide Recall of Metformin Hydrochloride Extended-Release Tablets 500mg Due to the Detection of N-nitrosodimethylamine (NDMA)

[Posted May 27, 2020]

Apotex Corp is voluntarily recalling all lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg within expiry to retail level. Apotex was notified by the U.S. Food and Drug Administration (US FDA) that one lot of Metformin Hydrochloride Extended-Release Tablets, USP was tested and showed results for N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) and recommended recall of the one tested lot. Apotex Corp has agreed to recall this lot, and out of an abundance of caution, the company is extending the recall to all lots of Metformin Hydrochloride Extended-Release Tablets in the US. Apotex stopped selling this product in the US in February 2019, and there remains only limited product on the market. To date, Apotex has not received any reports of adverse events related to use of the product.

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.

Metformin Hydrochloride Extended-Release Tablets, USP is a prescription oral product indicated as an adjunct to diet and exercise to improve blood sugar control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. The affected Metformin Hydrochloride Extended-Release Tablets, USP can be identified by NDC numbers stated on the product label.

Product Strength Pack Size NDC Number

Metformin Hydrochloride Extended-Release Tablets, USP 500mg 100’s Bottle 60505-0260-01


The affected Metformin Hydrochloride Extended-Release Tablets were distributed nationwide in the USA to Warehousing Chains. Apotex Corp. is in a process of notifying its affected direct account Wholesaler, Distributor, Chain Distribution and Warehousing Chains via mail (FedEx Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product.

Wholesalers, Distributors and Retailers should return the recalled product to the place of purchase. Anyone with an existing inventory of the product should quarantine the recalled lots immediately. Customers who purchased the impacted product directly from Apotex can call Inmar Rx Solutions at 1-888-985-9014 (option 1) (9:00am – 5:00-pm, EST Monday thru Friday), to arrange for their return.

Consumers with questions regarding this recall can contact Apotex Corp. by phone at 1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday) or email address [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.


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



Epinephrine Auto-Injector Devices by Anneal and Impax: CDER Alert-FDA Alerts Patients and Health Care Professional and About Device Malfunction

[Posted June 1, 2020]

ISSUE: FDA is alerting patients, caregivers and health care professionals to immediately inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3 mg to ensure the yellow “stop collar” in the device is present. If the auto-injector is missing the yellow “stop collar” component, the device has the potential safety risk of delivering a double dose of epinephrine to a patient.

BACKGROUND: Epinephrine Auto-Injector Devices are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis. RECOMMENDATION: Patients, pharmacists and health care professionals who have received Amneal or Impax’s epinephrine auto-injector after December 20, 2018, should immediately visually inspect the auto-injector to confirm the presence of the yellow “stop collar” by:

1. Removing the auto-injector from the carrying case.

2. Placing the auto-injector on a flat surface.

3. Locating the edge of the label that states, “Peel here for further instructions.” Lift the label edge until you see the clear part of the auto-injector.

4. Looking for the yellow “stop collar” inside the clear part of the auto-injector.


5. If the yellow “stop collar” is not visible inside the clear part of the auto-injector, gently rotate the blue sheath remover, without pulling or removing the blue sheath remover, to observe if the yellow “stop collar” comes into view inside the clear part of the auto-injector.If yellow “stop collar” is present, then the product is safe to use, and no further action is necessary. Re-wrap the label to its original position and place the auto-injector into the carrying case.

Epinephrine auto-injectors are not being recalled. FDA urges patients to use the epinephrine auto-injector they have on hand and be aware of the potential issues outlined in the statement above.

Health care 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.


Amneal Pharmaceuticals LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, Due to Detection of N-Nitrosodimethylamine (NDMA) Impurity


Amneal Pharmaceuticals LLC Bridgewater, New Jersey (Amneal), is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, within expiry to the Consumer Level. Amneal was notified by the U.S. FDA that the Agency’s testing of seven lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, showed N-Nitrosodimethylamine (NDMA) amounts above acceptable FDA levels. FDA recommended the recall of the seven tested lots. Amneal has agreed to this recall and has further decided to extend the recall to all lots within expiry of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, out of an abundance of caution. Further scientific evaluations are ongoing at Amneal.

To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.

Amneal’s Metformin Hydrochloride Immediate Release Tablets, USP are not affected by this recall.

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 found in water and foods, including meats, dairy products and vegetables.

Metformin HCl Extended Release Tablets, USP, 500 mg and 750 mg, manufactured by Amneal, are prescription, solid oral products that are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

The Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, subject to the recall, are identified by the NDC numbers stated on the product label.

Metformin HCl Extended Release Tablets, USP, 500 mg


NDC Pack Size 53746-178-01 100 count bottles 53746-178-05 500 count bottles 53746-178-10 1000 count bottles 53746-178-90 90 count bottles 53746-178-Bulk Bulk Box 65162-178-09 90 count bottles 65162-178-10 100 count bottles 65162-178-11 1000 count bottles 65162-178-50 500 count bottles

Metformin HCl Extended Release Tablets, USP, 750 mg

NDC Pack Size 3746-179-01 100 count bottles 53746-179-Bulk Bulk Box 65162-179-10 100 count bottles

The affected Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, lots were distributed nationwide in the US directly to Wholesalers, Distributors, Retailers and Repackagers.

Amneal is notifying its direct customers via mail (UPS Standard Overnight) by mailing a recall notification letter and is arranging for return of all the 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 may call Amneal at 1-833-582-0812 or email to [email protected], Monday – Friday, 8:00 am – 5:00 pm, EST, for further information.

Pharmacies should cease dispensing product. Amneal is notifying Retailers via mail (UPS Standard Overnight) who have been provided Amneal’s Metformin Hydrochloride Extended Release Tablets, USP, 500 mg or 750 mg, which will include instructions for retailer and consumer product return.

For information concerning this recall please call Amneal at 1-833-582-0812 or email to [email protected], Monday – Friday, 8:00 am – 5:00 pm, EST.

If you would like to report any adverse reactions or quality problems experienced with the use of this product you may contact Amneal Drug Safety by phone at 1-877-835-5472, Monday - Friday, 8:00 am – 6:00 pm, EST, or via e-mail at [email protected].






Two Neuromuscular Blocking Agents: CDER Alert - FDA Alerts Health Care Professionals to the Temporary Absence of Warning Statement on the Vial Caps


ISSUE: FDA is notifying health care professionals about the temporary absence of the “paralyzing agent” warning statement embossed on the vial caps of two neuromuscular blocking agents, vecuronium bromide for injection, 10 mg and 20 mg per vial and rocuronium bromide injection 50 mg/5 mL and 100 mg/10 mL vials.

As a temporary measure, to increase supply of these drugs, FDA is not objecting to the distribution of vecuronium bromide for injection and rocuronium bromide injection, starting June through September 2020 and June through July 2020, respectively, without the embossed “paralyzing agent” warning statement on the vial cap.

The following products are affected:

Rocuronium bromide injection by Gland Pharma and Mylan Institutional: NDC 68083-364-01 (Gland)

• NDC 68083-365-01 (Gland) • NDC 67457-228-05 (Mylan) • NDC 67457-228-10 (Mylan)

Vecuronium bromide injection manufactured by Gland Pharma and distributed by Fresenius Kabi:

• NDC 63323-781-21 • NDC 63323-782-23

BACKGROUND: Vecuronium bromide for injection and rocuronium bromide injection are commonly used to provide muscle relaxation during surgery or mechanical ventilation.

During the COVID- 19 pandemic, there has been an increased use of vecuronium bromide for injection and rocuronium bromide injection in intensive care unit (ICU) patients requiring mechanical ventilation. The COVID-19 pandemic has also caused supply chain disruptions contributing to a shortage of product components, such as embossed vial caps, used in manufacturing the container closure for these products.

Currently vecuronium bromide for injection and rocuronium bromide injection include a prominent “Paralyzing Agent” warning statement (in red bold font) on the container labeling which will remain on the vials.

RECOMMENDATION: The FDA recommends careful handling of these neuromuscular blocking agents as it is vital to prevent medication errors that could result in serious harm or death.

Health care providers should consider the following steps:

• Add an auxiliary warning label on the vial caps to help alert health care providers that the product is a neuromuscular blocking agent.

• Avoid storing the product so that only the cap is visible.


• Utilize barcode scanning when stocking medication cabinets and preparing or administering the product.

• Check the container label to ensure the correct product is being administered. • If these products are stored in automated dispensing cabinets, consider hospital protocols to

limit access and manage override removals. Health professionals and patients are encouraged to report adverse events and medication errors 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.


Apotex Corp. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets 500mg Due to the Detection of N-nitrosodimethylamine (NDMA)


Apotex is expanding the previously announced Retail Level recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg that was initiated on May 29, 2020 to Consumer Level.

Apotex was notified by the U.S. Food and Drug Administration (US FDA) that one lot of Metformin Hydrochloride Extended-Release Tablets, USP was tested and showed results for N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) and recommended recall of the one tested lot. Apotex Corp has agreed to recall this lot, and out of an abundance of caution, the company is extending the recall to all lots of Metformin Hydrochloride Extended-Release Tablets in the US. Apotex stopped selling this product in the US in February 2019, and there remains only limited product on the market. To date, Apotex has not received any reports of adverse events related to use of the product.

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.

Patients who have received impacted lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg or have questions regarding this recall please contact your pharmacy. Individuals should not interrupt their therapy, contact their health care provider for medical advice and should return the impacted product to their pharmacist.

Metformin Hydrochloride Extended-Release Tablets, USP is a prescription oral product indicated as an adjunct to diet and exercise to improve blood sugar control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. The affected Metformin Hydrochloride Extended-Release Tablets, USP can be identified by NDC numbers stated on the product label.

Product Strength Pack Size NDC Number Metformin Hydrochloride Extended-Release Tablets, USP 500mg 100’s Bottle 60505-0260-01

The affected Metformin Hydrochloride Extended-Release Tablets were distributed nationwide in the USA to Warehousing Chains. Apotex Corp. is in a process of notifying its affected direct account


Wholesaler, Distributor, Chain Distribution and Warehousing Chains via mail (FedEx Standard Overnight) by mailing a recall notification letter and is arranging for return of all recalled product.

Wholesalers, Distributors and Retailers should return the recalled product to the place of purchase. Anyone with an existing inventory of the product should quarantine the recalled lots immediately. Customers who purchased the impacted product directly from Apotex can call Inmar Rx Solutions at 1-888-985-9014 (9:00am – 5:00-pm, EST Monday thru Friday), to arrange for their return. Consumers with questions regarding this recall can contact Apotex Corp. by phone at 1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday) or email address [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.




Marksans Pharma Limited Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, Due to the Detection of N-Nitrosodimethylamine (NDMA)


Marksans Pharma Limited, India is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004, to the consumer level. FDA analysis has found the product to contain N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) of 96 ng/day.

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 found in water and foods, including meats, dairy products and vegetables. Marksans Pharma Limited has not received any reports of adverse events related to this recall to date.

Metformin Hydrochloride Extended-Release Tablets, USP 500mg is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in 100 count bottles with NDC code 49483-623-01. The affected Metformin Hydrochloride Extended-Release Tablets, USP 500mg, are white to off white, capsule shaped, biconvex tablets, debossed with ‘101’ on one side and plain on the other side.

Product name: Metformin Hydrochloride Extended Release Tablets USP, 500 mg, Lot #: XP9004, Expiry Date: 12/2020

The product can be identified by lot # XP9004 and expiration date 12/2020. Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004 was distributed by Time-Cap Labs, Inc. (located at 7 Michael Avenue, Farmingdale, New York 11735) nationwide in the USA to wholesalers who further distributed to pharmacies.


Marksans Pharma Limited is notifying its distributors and customers by issuing notification letter and press release and is arranging for return/replacement etc. of recalled product lot. Distributors/retailers that have Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004 which is being recalled should return to place of purchase.

Consumers with questions regarding this recall and return can contact Ms. Irene McGregor (Vice President, Regulatory Affairs) of Time-Cap Labs, Inc., located at 7 Michael Avenue, Farmingdale, New York 11735, by phone number 631-753-9090; ext. 160, [Monday to Friday 8am-5pm EST] or e-mail address [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.



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)


Teva Pharmaceuticals USA, Inc. Initiates Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP 500 mg and 750 mg Due to Detection of N-Nitrosodimethylamine (NDMA)


Teva Pharmaceuticals USA, Inc. is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1000 count bottles, in the United States to the consumer-level due to the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI).

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. Metformin Hydrochloride is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. The lots being recalled are packaged under the Actavis Pharma, Inc. label and are contained in the table below. They were distributed nationwide in the USA as retail bottles of 100 tablets and 1000 tablets to Teva’s direct customers between January 8, 2019 and May 27, 2020.

The affected Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, being recalled are described as:

• Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, white to off-white capsule shaped tablets, debossed with an Andrx logo with “571”on one side and “500” on the opposite side.

mailto:[email protected]


• Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, light yellow capsule shaped tablets, debossed with an Andrx logo with “577” on one side and “750” on the opposite side.

NDC Product Description Lot Number Expiration 62037-571-01 Metformin Hydrochloride Extended-Release

Tablets, USP 500 mg 100 Count 1329548A 06/2020

62037-571-01 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 100 Count

1338302M 10/2020


1348968M 10/2020


1348969M 11/2020


1348970M 10/2020


1376339M 09/2021


1323460M 06/2020


1330919M 06/2020


1338300A 10/2020


1341135M 12/2020


1391828M 11/2021


1333338M 08/2020


1333339A 08/2020


1354471A 02/2021

Teva is notifying its distributors and customers affected by this recall via FedEx overnight mailing. Patients taking Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. According to the US Food & Drug Administration, It could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their health care professionals. Please visit the agency’s website for more information at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin.

Customers and patients with medical-related questions, who wish to report an adverse event, or quality issues about the Teva products being recalled should contact Teva Medical Information by phone at:


888-838-2872, option 3, then, option 4. Live calls are received Monday-Friday, 9:00 am to 5:00 pm Eastern Time with voicemail available 24 hours/day, 7 days/week or by email at [email protected].

Patients wishing to return product may contact Teva’s product recall processor to obtain instructions and a return kit for returning their medication:

• Contact Inmar at 1-855-532-1850 (Hours of Operation: 9 am to 5 pm Eastern Time, Monday – Friday) or email Inmar at: [email protected].

• Inmar will provide the materials needed to return their medication and instructions for reimbursement.





mailto:[email protected]


STUDIES AND RECENT TOPICS

COVID patients given malaria drug didn't see significant improvements: studies

May 14, 2020

Patients given the malaria drug touted by President Donald Trump as a potential treatment for COVID-19 did not improve significantly over those who did not, according to two new studies published in the medical journal BMJ on Thursday.

Source: reuters.com

Comparative Effectiveness of Monotherapies for Relapsed, Refractory Hodgkin Lymphoma

May 14, 2020

The KEYNOTE-204 study showed that pembrolizumab is superior to brentuximab vedotin in terms of survival outcomes while maintaining a consistent safety profile in patients with relapsed or refractory classic Hodgkin lymphoma.

Results of the study will be presented at the American Society of Clinical Oncology (ASCO) Virtual Scientific Program (May 29-31, 2020).

Source: journalofclinicalpathways.com

Drug Combo Offers Hope against Advanced Bladder Cancer

May 14, 2020

A combination of chemotherapy and immunotherapy may slow the progress of metastatic bladder cancer and extend survival, a clinical trial suggests.

Current treatment for advanced bladder cancer is chemotherapy, but adding the immunotherapy drug atezolizumab (Tecentriq) appears to help more patients fight this disease. It strikes 81,000 Americans a year and kills 18,000.

Source: healthday.com

Impact of COVID-19 Leaves Lasting Impression on Pharmacies

May 14, 2020

The coronavirus disease 2019 (COVID-19) pandemic is likely to leave a lasting impression on pharmacy and the services provided by pharmacists, according to some industry experts with the Pharmacy Quality Alliance (PQA).

In a virtual session of the 2020 PQA Annual Meeting on Thursday, panelists Susan Cantrell, RPh, CAE, CEO of the Academy of Managed Care Pharmacy (AMCP), and Ceci Connolly, president and CEO of the Alliance of Community Health Plans, discussed with moderator Laura Cranston, RPh, CEO of PQA, supply chain issues that have occurred as a result of the pandemic, as well as the quick evolution of pharmacy practice that has occurred out of necessity for socially distant patient care.

Source: medpagetoday.com


Remdesivir Distribution Causes Confusion, Leaves Some Hospitals Empty-Handed

May 14, 2020

States are beginning to receive cases of an experimental COVID-19 drug that the Food and Drug Administration authorized for emergency use on May 1.

But the distribution process so far has puzzled some hospitals and states about why they've been left empty-handed.

Source: npr.org

New Insights Into Serum Total and Estimated Free Estradiol Concentrations in Men of All Ages

May 18 ,2020

Testosterone deficiency syndrome is a condition in which a man's body does not produce sufficient testosterone (T). This condition generally affects older men, but younger patients can also be affected by a variety of reasons. Treatment consists of the replacement of these hormones.


Tests before Testosterone Supplements

May 18, 2020

Studies have shown that testosterone supplements used to treat testosterone deficiency can lead to higher estradiol levels in fat, especially in men who are obese. This led Susan Chadid and colleagues to conduct a study on the topic, published in the Journal of the Endocrine Society.


Triple Therapy Beneficial in Treating Pulmonary Arterial Hypertension

May 18, 2020

For patients with pulmonary arterial hypertension, the current recommended treatment is initial double oral combination therapy. However, the advent of initial triple oral combination therapy could be on the horizon. A team, led by Kelly Chin, MD, UT Southwestern Medical Center, evaluated the efficacy and safety of initial triple oral therapy with selexipag, macitentan and tadalafil compared to initial double oral therapy with macitentan and tadalafil.

Source: mdmag.com

In Utero Steroids Tied to Childhood Mental Disorders

May 19, 2020

Prenatal exposure to corticosteroids was associated with increased rates of mental and behavioral disorders in childhood, according to a Finnish registry study.

Among 670,097 children, the risk for developing a mental or behavioral disorder in early childhood was modestly higher for those whose mothers took corticosteroids in pregnancy compared with unexposed kids (adjusted hazard ratio 1.33, 95% CI 1.26-1.41, P<0.001), reported Katri Räikkönen, PhD, of the University of Helsinki, and colleagues.



Childhood vaccine rates plummet amid coronavirus pandemic, risking new health crisis

May 20, 2020

Childhood vaccine rates for preventable diseases like measles and whooping cough have fallen during the COVID-19 pandemic, raising the possibility of an additional health crisis.

In New York City, Mayor Bill de Blasio (D) on Wednesday said the number of vaccine doses administered from March 23 to May 9 fell 63 percent compared with the same period last year.

Source: thehill.com

Mom's Oral Fluconazole Linked to Bone and Muscle Defects in Baby

May 21, 2020

Oral fluconazole in pregnancy was linked to increased risk for congenital bone and muscle abnormalities in a population-based cohort study.

Mothers who took low-dose fluconazole -- an antifungal agent used to treat vaginal yeast infections, among other things -- during the first trimester were 30% more likely to deliver infants with musculoskeletal malformations (relative risk 1.30, 95% CI 1.09-1.56), reported Yanmin Zhu, PhD, of the Brigham and Women's Hospital and Harvard School of Medicine in Boston, and colleagues.


US seeking industry cooperation on future medical supplies

May 21, 2020

U.S. officials are invoking a rarely used provision of American law that would shield companies from antitrust regulations to help the country from again running out of medical supplies in a pandemic.

The government began formal discussions Thursday with private industry representatives on a cooperative five-year agreement to ensure supplies of protective materials, medical equipment, medicine and vaccines.

Source: apnews.com

Survey: 72% of consumers have changed healthcare use since COVID-19 pandemic

May 21, 2020

COVID-19 has impacted the healthcare of 72% of consumers, a recent survey found, with a majority saying they have already delayed or plan to put off health procedures.

The survey, released Thursday by the Alliance of Community Health Plans (ACHP) and the Academy of Managed Care Pharmacy (AMCP), underscores the issues providers face in convincing consumers to return for in-person care that has been delayed due to the pandemic.

Source: fiercehealthcare.com

US pledges up to $1.2 billion to access 300 million doses of experimental COVID-19 vaccine

May 21, 2020

The United States has pledged to pay as much as $1.2 billion to get early access to 300 million doses of an experimental COVID-19 vaccine being developed and tested in England.


The vaccine is being developed by the University of Oxford’s Jenner Institute and licensed to British drugmaker AstraZeneca.

Source: usatoday.com

U.S. doctors call for remdesivir data to guide coronavirus treatment

May 21, 2020

U.S. doctors and others in the scientific community are calling for the release of data that convinced health regulators to authorize emergency use of Gilead Sciences Inc’s antiviral drug remdesivir to treat COVID-19, so they can direct limited supplies on the right patients.

Source: reuters.com

Half of Americans in new poll say they would get COVID-19 vaccine

May 27, 2020

Roughly half of the Americans surveyed in a poll released Wednesday said they would get a vaccine to prevent COVID-19.

The Associated Press-NORC Center for Public Affairs Research poll found that 49 percent of respondents said they would get a vaccine for the disease, which is caused by the novel coronavirus. Twenty percent of respondents said they would not, and 31 percent said they weren’t sure yet.

Source: thehill.com

Coronavirus Testing Machines Are Latest Bottleneck In Troubled Supply Chain

May 28, 2020

Coronavirus testing in the U.S. has run into a number of snags, from a lack of nasal swabs to not enough chemicals needed to run the tests.Now there's a new bottleneck emerging: A shortage of the machines that process the tests and give results.

Source: npr.org

First human trial of potential antibody treatment for Covid-19 begins

June 2, 2020

Eli Lilly and Company said Monday it has started the first human trial of an antibody therapy designed to treat Covid-19.

The first phase of the trial will test whether the therapy is safe and well-tolerated; those results are expected in late June. The first Covid-19 patients being treated with the therapy are hospitalized at New York University's Grossman School of Medicine in New York, Cedars-Sinai in Los Angeles and Emory University in Atlanta, the company told CNN.

Source: cnn.com


Gilead's next step on coronavirus: inhaled remdesivir, other easier-to-use versions

June 2, 2020

Gilead Sciences Inc (GILD.O) is developing easier-to-administer versions of its antiviral treatment remdesivir for COVID-19 that could be used outside of hospitals, including ones that can be inhaled, after trials showed moderate effectiveness for the drug given by infusion.

Source: reuters.com

U.S. seeks to 'onshore' drug production in response to COVID-19. Is pharma even interested?

June 3, 2020

With the COVID-19 pandemic shining a spotlight on the global pharmaceutical supply chain, U.S. legislators have put forward a raft of legislation that would seek to "onshore" drug manufacturing at the expense of major producers abroad, particularly China.

Guess who's wary of that proposal? Big Pharma.

Source: fiercepharma.com

Clinical Challenges: Molecular Testing in CRC

June 8, 2020

Molecular testing for colorectal cancer (CRC) has evolved considerably over the past decade and will continue to do so as new mutations and biomarkers associated with the disease are identified.

More than 30 years ago, researchers proposed a model whereby a series of genetic events led to the transition of colonic adenomas into colorectal cancer. According to the model, point mutations in KRAS were an early event in pathogenic transition. However, almost two decades would pass before proof emerged to show that KRAS mutation was associated with poor response to the EGFR inhibitor cetuximab (Erbitux), which had become standard therapy for many patients with colorectal cancer. Within a couple of years, testing for KRAS mutation status had become standard practice for guiding treatment decisions for patients with colorectal cancer.


Even Frail Seniors Benefit From Hypertension Med Adherence

June 8, 2020

Older individuals who stuck with their antihypertensive drug treatment tended to have a lower longer-term risk of mortality, with the magnitude of benefit varying across the spectrum of clinical status, according to researchers from Italy.


Postpartum Opioid Scripts Tied to Risk of Serious Events

June 8, 2020

The number of opioid prescriptions that women filled after childbirth was associated with an increased risk of serious opioid-related events (SOREs), according to a Tennessee-based cohort study.

Women that filled one opioid prescription in the year after childbirth had a 40% increased risk of SOREs (adjusted hazard ratio 1.40, 95% CI 1.30-1.60), including persistent opioid use, opioid use disorder,


buprenorphine or methadone prescription fills, opioid overdose, or death, reported Sarah Osmundson, MD, of the Vanderbilt University Medical Center in Nashville.


Clinical Challenges: Indolent Mantle Cell Lymphoma

June 10, 2020

Patients who present with indolent mantle cell lymphoma (MCL) have a better prognosis and can often defer treatment for months or sometimes years, but evidence on the best approach for this subgroup is sparse.

"Mantle cell lymphoma is increasingly recognized as a heterogeneous lymphoma," Peter Martin, MD, Chief of the Lymphoma Program at Weill Cornell Medicine and NewYork-Presbyterian Hospital in New York City, told MedPage Today. "Not only are there recognized biological variants in terms of how they arise, there are also variants in terms of how the same subtype of mantle cell lymphoma might behave from person to person [and] variations in how it changes over time."


FDA data shows numerous drugs in shortage, including a leading antidepressant

June 10, 2020

When Dr. Jeremy Faust ordered medications for a coronavirus patient he planned to put on a mechanical ventilator several weeks ago, he saw warning messages pop up on his computer.

“We're very, very accustomed to seeing drug shortages and alarms coming up on our screen,” said Faust, an emergency physician at Brigham and Women’s Hospital in Boston. “But during this crisis, it’s become a lot more frequent.”

Source: usatoday.com


RECALLS

Product Type Product Description Classification Code Info Reason for Recall Recalling Firm

Drugs NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-329-01.

Class I Lots: M329H18-1, Exp. JUL-2020; M329J18-1, M329J18-2, M329J18-3 Exp. AUG-2020; M329M18-2 Exp. NOV-2020, M329A19-1 Exp. DEC-2020.

Superpotent Drug. Acella Pharmaceuticals, LLC

Drugs NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-330-01.

Class I Lots: M330J18-2A, M330J18-3 Exp. AUG-2020

Lots: M330J18-2A, M330J18-3 Exp. AUG-2020

Acella Pharmaceuticals, LLC

Drugs NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-331-01.

Class I Lots: M331G18-1 Exp. JUN-2020, M331J18-1, M331J18-2, Exp. AUG-2020, M331M18-1, M331M18-2 Exp. NOV-2020

Superpotent Drug. Acella Pharmaceuticals, LLC

Drugs Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials (NDC 63323-162-00); 25 x 1 mL Single Dose Vials per tray (NDC 63323-162-01); For IM or IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Class I Lot #: 6118737, 6118902, Exp 04/2020; 6119052, Exp 05/2020; 6119752, Exp 08/2020; 6122349, Exp 07/2021; 6122538, Exp 09/2021

Presence of Particulate Matter - found in reserve sample vials at the firm.

Fresenius Kabi USA, LLC

Drugs Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05),

Class II Lot #: a) 71846B, Exp 6/2021; b) 71726A, Exp 6/2020; 71846B,

Failed dissolution specification: The dissolution test at the 24 month time point (end of

West-Ward Columbus Inc



Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.

71853A, Exp 6/2021

shelf life) yielded an out of specification result.

Drugs Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC 55289-866-06), b) 10-count (NDC 55289-866-10), c) 14-count (NDC 55289-866-14), d) 20-count (NDC 55289-866-20), e) 28-count (NDC 55289-866-28), f) 30-count (NDC 55289-866-30), g) 60-count (NDC 55289-866-60), h) 120-count (NDC 55289-866-98), i) 210-count (NDC 55289-866-71), j) 300-count (NDC 55289-866-87), k) 400-count (NDC 55289-866-74), Rx only, PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127

Class II Lots: a) L18B72, Exp 12/31/2020; b)I18B83, Exp 06/30/2020 ; c) H18B11, Exp 06/30/2020; I18A53, Exp 06/30/2020; J18F97, Exp 10/31/2020; K18A33, Exp 11/30/2020; K18D17, Exp 11/30/2020; L18A11, Exp 12/31/2020; L18A29, Exp 12/31/2020; L18D81, Exp 12/31/2020; d) H18F60, Exp 06/30/2020; I18C26, Exp 06/30/2020; I18D61, Exp. 06/30/2020; J18B80, Exp 10/31/2020; K18C97 Exp 11/30/2020; L18B30, Exp. 12/31/2020; L18D25, Exp 12/31/2020; L18E50 Exp 12/31/2020; e) I18D07, Exp. 06/30/2020; J1E02, Exp 10/31/2020;

Failed dissolution specifications

PD-Rx Pharmaceuticals, Inc.



J18E62 Exp 10/31/2020; K18E98 Exp. 11/30/2020; L18C54, Exp 12/31/2020; f) H18E18 Exp. 06/30/2020, I18F94 Exp. 09/30/2020, J18E42, Exp. 10/31/2020, L18B56 Exp. 12/31/2020; g) J18C84 Exp. 10/31/2020, A19B70 Exp. 01/31/2021; h) K18E92 Exp. 11/30/2020; i) I18E80 Exp. 06/30/2020, K18A19 Exp. 11/30/2020; j) F18E11 Exp. 06/30/2020, G18E66 Exp. 06/30/2020, H18E72 Exp. 06/30/2020, I18E75 Exp. 09/30/2020, I18E95 Exp. 09/30/2020, I18F64 Exp. 09/30/2020; k) A19D44 Exp. 08/31/2020, H18E76 Exp. 06/30/2020, I18F21 Exp. 09/30/2020, L18B91 Exp. 12/31/2020



Drugs LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in 1 patch/box (NDC 10882-527-01); 30 patches/box (NDC 10882-527-02 and 10882-527-04), Manufactured for: JAR Laboratories, Elmhurst, IL.

Class II Batch #: 1180103, Exp 2021.01.02; 180104, Exp 2021.01.03; 80105, Exp 2021.01.04; 180106, Exp 2021.01.05; 80107, Exp 2021.01.06.

CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.

Wuhan Bingbing Pharmaceutical Co., Ltd.

Drugs LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches per box, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1023-1.

Class II Batch #: 170527, Exp 2020.05



Drugs Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1090-1.

Class II Batch #: 170731, Exp 2020.07; 180504; Exp 2021.05



Drugs Maximum Strength Lidocaine Cold & Hot Patch

Class II Batch #: 170614, Exp

CGMP Deviations: due to the loss of

Wuhan Bingbing



(lidocaine 4%, menthol 1%), 5 patches per box, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895; NDC 66902-218-05.

2020.06.13; 180108, Exp 2021.01.07; 180109, Exp 2021.01.08; 180110, Exp 2021.01.09; 180111, Exp 2021.01.10, 180112, Exp 2021.01.11; 180113, Exp 2021.01.12; 180317, Exp 2021.03.16; 180318, Exp 2021.03.17

product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.

Pharmaceutical Co., Ltd.

Drugs Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103, NDC 71092-9977-02

Class II Lot #:17010401181119190927, EXP 12/2020, 1701040118111919092725200122, EXP.12/2020

Failed impurities/ degradation specifications: Out of specification for organic impurities.

TRIOVA PHARMACEUTICALS LLC

Drugs Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 5 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0971-02

Class II Lot #: 42614718, Exp. date 02/2021

Some bottles may contain mixed strengths of the product.

Teva Pharmaceuticals USA

Drugs Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 15 mg, 100 count

Class II Lot #: 42617008, Exp. date 10/2021





bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0777-02

Drugs Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 20 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0973-02

Class II Lot #: 42617891, exp. date 01/2022



Drugs Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit dose carton (NDC 0904-0430-06), Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152.

Class II Lot #: a) R00828D, Exp. date 08/2020, b) R00732D, Exp. date 05/2020; R00783D, Exp. date 06/2020; R00827D, Exp. date 08/2020

Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.

The Harvard Drug Group

Drugs Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL Single Dose Vials (NDC 63323-162-03), 25 x 2 mL Single Dose Vials per tray (NDC 63323-162-02); For IM use only, Not for IV use, Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Class II Lot #: 6119229, 6119273, Exp 06/2020; 6119843, Exp 09/2020; 6121115, Exp 02/2021; 6121451, 6121452, 6121496, Exp 03/2021

Presence of Particulate Matter - found in reserve sample vials at the firm.

Fresenius Kabi USA, LLC

Drugs Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Packaging,

Class II Lots 179605, Exp 06/30/2020; 181105, Exp 08/31/2020;

Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24

American Health Packaging



Columbus, Ohio 43217, NDC Carton 62584-693-21; NDC Unit Dose 62584-693-11

183019, Exp 01/31/2021

month time point (end of shelf life).

Drugs Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only, 10 vials/carton, Made in Italy Distributed by Roerig Division of Pfizer Inc. New York, NY 10017 vial NDC 0049-0013-81, carton NDC 0049-0013-83

Class II Lot # 3301612, EXP 02/2022

Presence of Particulate Matter: particulate matter identified after reconstitution.

Pfizer Inc.

Drugs Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Nagpur - 441 108, India, NDC 68180-513-03.

Class II Lot # Q900683, Exp. 10/31/2022

Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.

Lupin Pharmaceuticals Inc.

Drugs oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Injection for IV Use, Rx only, QuVa Pharma 1075 West Park One Drive, Suite 100 Sugar Land, TX 77478 888-339-0874, NDC 70092-1068-07

Class II Lot#: 30010515 Subpotent drug - Product did not contain drug.

QuVa Pharma, Inc.

Drugs Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA, For repackaging by: AvKare Inc., Pulaski, TN 38478, Bulk Shipment, NDC 59746-247-97.

Class III Lot #s 19P0437 & 19P0438, Exp. 09/30/2021.

Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.

Jubilant Cadista Pharmaceuticals, Inc.

Drugs Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50,

Class III Lot #: a) 25634, b) 25633; Exp. 09/30/2021

Presence of Foreign Substance consistent with granules from desiccant packs

AVKARE Inc.



Manufactured for: AvKARE, Inc. Pulaski, TN 38478.

used during storage

Drugs Clonodine Hydrochloride Tablets, USP 0.1 mg 100-count bottles, Rx only, Manufactured by: Unichem Laboratories LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for : Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-135-01

Class III Lot #: GCLL19034, GCLL19035, GCLL19036, Exp. 4/30/2021; GCLL19044, Exp. 6/30/2021

Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container.

UNICHEM PHARMACEUTICALS USA INC

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


CURRENT DRUG SHORTAGES

Tacrolimus injection May 21, 2020 Reasons for shortage

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

• Astellas has Prograf 5 mg/mL 1 mL ampules available https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=588 Tacrolimus Capsules May 21, 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.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-ShortageDetail.aspx?id=567&loginreturnUrl=SSOCheckOnly Sulfacetamide Sodium and Prednisolone Acetate Ophthalmic Ointment May 21, 2020 Reasons for shortage

• Allergan did not provide a reason for the shortage. They are the sole suppliers of sulfacetamide sodium and prednisolone acetate ophthalmic ointment.

Estimated Resupply Dates • Allergan has Blephamide ophthalmic ointment on 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=611 Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment May 21, 2020 Reasons for shortage

• Bausch Health did not provide a reason for the shortage.


• Novartis has Maxitrol ointment available. • Perrigo did not provide a reason for the shortage. • Sandoz did not provide a reason for the shortage.

Estimated Resupply Dates • Bausch Health has neomycin/polymyxin B/dexamethasone ophthalmic ointment in 3.5 gram

tubes on back order and the company estimates a release date of early- to mid-June 2020. • Sandoz has neomycin/polymyxin B/dexamethasone ophthalmic ointment in 3.5 gram tubes on

back order and the company estimates a release date in early- to mid-June 2020. • Perrigo has temporarily discontinued neomycin/polymyxin B/dexamethasone ophthalmic

ointment in 3.5 gram tubes and the company cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=645 Metronidazole Hydrochloride Injection May 21, 2020 Reasons for shortage

• Baxter has metronidazole injection available. • BBraun has metronidazole injection available. • Pfizer did not provide a reason for the shortage. • Sagent launched metronidazole injection in October 2019.

Estimated Resupply dates • Pfizer has metronidazole on intermittent back order and the company estimates the next

release in May 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=316 Atropine Ophthalmic Solution May 21, 2020 Reasons for shortage

• Akorn did not provide a reason for the shortage. • Altaire has Homatropine ophthalmic solution on shortage due to manufacturing delays.

Estimated Resupply dates • Altaire has Homatrapine ophthalmic 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=514 Amphetamine Mixed Salts, Immediate-Release Tablets May 21, 2020 Reasons for 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 presentations on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=535 Sterile Talc May 22, 2020 Reasons for shortage

• Lymol has Sclerosol and talc powder on shortage due to manufacturing delays. • Novatech SA did not provide a reason for the shortage.

Estimated Resupply Dates • Lymol has Sclerosol and talc powder on long-term back order and the company cannot estimate

a release date. • Novatech has Steritalc 2 grams in 50 mL vials available with short expiration dating (June 2020).

The company estimates additional product will be available by July 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=260 Prednisolone Acetate 1% Ophthalmic Suspension May 22, 2020 Reason for shortage

• Allergan has Pred Forte available. • Greenstone did not provide a reason for the shortage. • Sandoz has prednisolone acetate ophthalmic suspension available

Estimated Resupply Dates • Greenstone has prednisolone acetate 1% ophthalmic suspension presentations on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=536 Polyvinyl Alcohol (Artificial Tears) Ophthalmic Solution May 22, 2020 Reason for shortage

• Akorn did not provide a reason for the shortage. • Altaire is not currently marketing polyvinyl alcohol 1.4% ophthalmic solution. • Major has Liquitears on shortage because they are updating the NDC number. • Ocusoft has Tears again on shortage because the product was recalled. • Rugby has Artificial Tears solution on shortage because they are updating the NDC number.

Estimated Resupply Dates • Akorn has Artificial Tears Solution ophthalmic drops on back order and the company cannot

estimate a release date. • Major has Liquitears ophthalmic drops temporarily discontinued and the company cannot

estimate a release date. • Rugby has Artificial Tears solution temporarily discontinued and the company cannot estimate a

release date. • Ocusoft has Tears Again 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=451


Hydroxyprogesterone Caproate Injection May 22, 2020 Reason for shortage

• AMAG has Makena vials available. • American Regent has hydroxyprogesterone injection available. • AuroMedics has hydroxyprogesterone injection available. • Mylan has hydroxyprogesterone injection available. • Prasco discontinued the 5 mL vials in mid-2019 and the 1 mL vials in late-2019. • Slayback Pharma has hydroxyprogesterone injection available.

Estimated Resupply Dates • Not provided

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=501 Griseofulvin Oral Presentation May 22, 2020 Reason for shortage

• Amneal has griseofulvin tablets available. • Cipla has griseofulvin suspension available. • Rising discontinued griseofulvin products. • Sandoz has griseofulvin tablets available. • Teva has griseofulvin suspension available.

Estimated Resupply Dates • Not provided

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=579 Fluorescein Sodium and Proparacaine Hydrochloride Ophthalmic Solution May 22, 2020 Reason for shortage

• Altaire has recalled several medications due concerns over lack of sterility assurance. More information can be found at: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-multiple-ophthalmic-products-sold-ocusoft.

• OCuSOFT discontinued Flucaine in January 2020. Estimated Resupply Dates

• Altaire has fluorescein/proparacaine 5 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=581 Lorazepan Tablets May 26, 2020 Reason for 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 • 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.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=480 Eptifibatide Injection May 26, 2020 Reason for shortage

• Accord has temporarily discontinued eptifibatide injection. • Akorn did not provide a reason for the shortage. • Amneal did not provide a reason for the shortage. • Auromedics did not provide a reason for the shortage. • Baxter has eptifibatide injection available. • Merck did not provide a reason for the shortage. • Mylan has eptifibatide injection available. • Sagent states the shortage is due to manufacturing delay. • Slate Run has eptifibatide injection available.

Estimated Resupply Dates • Akorn has eptifibatide 0.75 mg/mL in 100 mL vials and 2 mg/mL in 10 mL vials on back order and

the company estimates a release date in mid-June 2020. • Amneal has eptifibatide 0.75 mg/mL in 100 mL vials and 2 mg/mL in 10 mL vials on back order

and the company cannot estimate a release date. • Auromedics has eptifibatide 0.75 mg/mL and 2 mg/mL in 100 mL vials on intermittent back

order and the company is releasing product as it becomes available. • Merck has Integrilin 2 mg/mL in 100 mL vials on back order and the company cannot estimate a

release date. • Sagent has eptifibatide 0.75 mg/mL in 100 mL vials and 2 mg/mL in 10 mL vials on back order

and the company estimates release dates in June 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=661 Doxycycline Hyclate Injection May 26, 2020 Reason for 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 early- to mid-June 2020. • Mylan Institutional has doxycycline 100 mg vials on 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=559 Dexrazoxane Injection May 26, 2020 Reason for 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

early-June 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&loginreturnUrl=SSOCheckOnly Cosyntropin Injection May 26, 2020 Reason for shortage

• Amphastar has Cortrosyn on shortage due to increased demand. • Mylan Institutional did not provide a reason for the shortage. • Sandoz did not provide a reason for the shortage.

Estimated Resupply Dates • Mylan Institutional has cosyntropin 0.25 mg vials on 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=522 Clindamycin Phosphate Injection May 27, 2020 Reason for 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 intermittent back order and the

company is releasing product as it becomes available. • 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. The 150 mg/mL 2 mL vials are on back order and the company estimates a release date of June 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 Amifostine Injection May 27, 2020 Reason for shortage

• Clinigen is the sole supplier of amifostine injection (Ethyol). Clinigen did not provide a reason for the shortage.

Estimated Resupply Dates • Clinigen has Ethyol 500 mg vials with a short expiry of October 2020 on allocation. The company

cannot estimate a release date for new product. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=662 Promethazine Injection May 28, 2020 Reason for shortage

• Hikma had promethazine injection on shortage due to increased demand. • X-Gen has promethazine injection available.

Estimated Resupply Dates • All marketed presentations are available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=460 Melphalan Injection May 28, 2020 Reason for shortage

• Athenex did not provide a reason for the shortage. • Dr. Reddy's has melphalan injection available. • Fresenius Kabi has melphalan injection available. • Meitheal has melphalan injection available. • Mylan Institutional did not provide a reason for the shortage. • Par discontinued melphalan injection in January 2020. • Sagent is not currently marketing melphalan injection. • Spectrum has Evomela injection available.



• Mylan has melphalan 50 mg vials on back order and the company estimates a release date of late-July 2020.

• Teva has melphalan 50 mg vials 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=525 Hyoscyamine Sulfate Injection May 28, 2020 Reason for shortage

• Mylan Institutional did not provide a reason for the shortage. • BPI Labs has hyoscyamine sulfate injection available.

Estimated Resupply Dates • Mylan Institutional has Levsin 1 mL ampules on back order and the company estimates a release

date of mid-July 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=615 Acetazolamide Injection May 28, 2020 Reason for 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 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=528 Valsartan Tablets May 29, 2020 Reason for 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 probably 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, Macleods, and Novartis are not affected by this recall. • Aurobindo, and Macleods refuse to provide updated availability information. • Cadista did not provide a reason for the shortage. • Lupin is not actively marketing valsartan tablets. • Mylan has valsartan tablets available. • 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 80 mg, 160 mg, and 320 mg 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. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=444 Mycophenolate Mofetil Capsules and Tablets May 29, 2020 Reason for shortage

• Accord has mycophenolate capsules and tablets available. • Ascend 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. • Genentech has Cellcept available. • Sandoz did not provide a reason for the shortage.

Estimated Resupply Dates • Ascend has all mycophenolate mofetil presentations on intermittent back order and the

company is releasing product as it becomes available. • Hikma has mycophenolate mofetil 250 mg capsules in 100 count and 500 count and 500 mg

tablets in 100 count and 500 count on allocation. • Mylan has mycophenolate mofetil 250 mg capsules in 100 count bottles on back order and the

company estimates a release date in mid-July 2020. • Sandoz has mycophenolate mofetil 250 mg capsules in 1,440 count 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=448 Lithium Oral Solution May 29, 2020 Reason for 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

Hydroxychloroquine Sulfate Tablets May 29, 2020 Reason for shortage

• Amneal has hydroxychloroquine 200 mg tablets on shortage due to increased demand. • Amneal has increased production of hydroxychloroquine tablets. Additional information is

available at https://investors.amneal.com/news/press-releases/press-release-


details/2020/Amneal-Accelerates-Distribution-and-Production-of-Hydroxychloroquine-Sulfate-to-Meet-Potential-Needs-of-COVID-19-Patients-Nationwide/default.aspx

• Concordia has Plaquenil 200 mg tablets available. • Dr. Reddy's did not provide a reason for the shortage. • Major has temporarily discontinued hydroxychloroquine tablets. • Mylan has hydroxychloroquine 200 mg tablets available. • Prasco had hydroxychloroquine 200 mg tablets on shortage due to increased demand. • Rising has hydroxychloroquine tablets on shortage due to increased demand. • Sandoz has donated product to support the COVID-19 pandemic response. Additional

information is available at https://www.sandoz.com/news/media-releases/novartis-commits-donate-130-million-doses-hydroxychloroquine-support-global

• Sandoz is allocating remaining hydroxychloroquine tablets. • Sun Pharma did not provide a reason for the shortage. • Teva has hydroxychloroquine tablets on shortage due to increased demand. • Zydus has hydroxychloroquine 200 mg tablets on shortage due to increased demand.

Estimated Resupply Dates • Amneal has hydroxychloroquine 200 mg tablets in 100 count on allocation to wholesalers.

Amneal is also allocating supplies to Health Warehouse online pharmacy. The pharmacy will confirm the product has been prescribed for an FDA approved indication before filling any prescriptions. Orders can be placed at https://try.healthwarehouse.com/hydroxy/ or by calling 800-748-7001.

• Dr. Reddy's has hydroxychloroquine 200 mg tablets in 100 and 500 count bottles on allocation to contracted customers.

• Major has hydroxychloroquine 200 mg tablets in 50 count and 100 count on back order and the company cannot estimate a release date.

• Rising has hydroxychloroquine 200 mg tablets in 100 count and 500 count bottles on intermittent back order and the company is allocating product when it becomes available.

• Sandoz has hydroxychloroquine 200 mg tablets in 100 count and 500 count bottles on allocation to current customers. New customers can request product by contacting US department of Health and Human Services at 202-690-6343 or [email protected].

• Sun Pharma has hydroxychloroquine 200 mg tablets in 100 count on back order and the company estimates a release date in mid-June 2020.

• Teva has hydroxychloroquine 200 mg tablets in 100 count and 500 count on back order and the company estimates release dates in late-June 2020 for the 100 count bottles and late-July 2020 for the 500 count bottles.

• Zydus has hydroxychloroquine 200 mg tablets in 100 count and 500 count bottles on allocation to current customers.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=646 Albuterol Sulfate Metered Dose Inhalers May 29, 2020 Reason for 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 available. • 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.

• Prasco has albuterol sulfate HFA 18 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

Vecuronium Bromide Injection June 1, 2020 Reason for shortage

• AuroMedics did not provide a reason for the shortage. • Pfizer has vecuronium on shortage due to increased demand. • Teva has vecuronium available. • Mylan Institutional did not provide a reason for the shortage. • Sun Pharma has vecuronium on shortage due to increased demand. • Fresenius Kabi has vecuronium on shortage due to increased demand.

Estimated Resupply Dates • AuroMedics has vecuronium 10 mg and 20 mg vials on back order and the company cannot

estimate a release date. • Fresenius Kabi has vecuronium 20 mg vials on back order and the company cannot estimate a

release date. The 10 mg vials are on back order and the company estimates a release date of mid-July 2020.

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

• Pfizer has vecuronium 20 mg vials on back order and the company estimates a release date of February 2021.

• Sun Pharma has vecuronium 10 mg and 20 mg vials on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=167

Testosterone Enanthate Intramuscular Injection June 1, 2020 Reason for shortage

• Hikma has testosterone enanthate available. • Teva did not provide a reason for the shortage.

Estimated Resupply Dates • Hikma has testosterone enanthate 200 mg/mL 5 mL vials on allocation. • Teva has testosterone enanthate 200 mg/mL 5 mL vials temporarily unavailable with no

estimated release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=498


Sodium Bicarbonate Injection June 1, 2020 Reason for shortage

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

were discontinued in December 2019. Estimated Resupply Dates

• Amphastar has 8.4% sodium bicarbonate 50 mL syringes on allocation. • Fresenius Kabi has 8.4% sodium bicarbonate 50 mL vials on back order and the company

estimates a release date of mid-June 2020. • 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 June 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.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=293

Ropivacaine Injection June 1, 2020 Reason for 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

estimates a release date of early- to mid-June 2020. The 2 mg/mL 100 mL bottles are on back order and the company estimates a release date of early- to mid-June 2020.

• Pfizer has ropivacaine 10 mg/mL 10 mL vials available in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=384

Ketamine Injection June 1, 2020 Reason for 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.



• 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-June 2020.

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


Dexamethasone Sodium Phosphate Injection June 1, 2020 Reason for shortage

• American Regent is not marketing dexamethasone sodium phosphate injection at this time. • AuroMedics did not provide a reason for the shortage. • Fresenius Kabi has dexamethasone sodium phosphate presentations available. • Mylan Institutional has dexamethasone injection available. • Hikma had dexamethasone injection on shortage due to increased demand. • Somerset Therapeutics has 10 mg/mL 1 mL and 10 mL vials available.

Estimated Resupply Dates • AuroMedics has dexamethasone sodium phosphate 4 mg/mL 1 mL, 5 mL, and 30 mL vials on

intermittent back order and the company is releasing product as it becomes available. • Hikma has dexamethasone sodium phosphate 4 mg/mL 1 mL vials on allocation.


Buprenorphine Hydrochloride Injection June 1, 2020 Reason for 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 October 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=419

Benztropine Mesylate Injection June 1, 2020 Reason for 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 <6 months. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=497


Acetylcysteine Oral and Inhalation Solution June 1, 2020 Reason for shortage

• American Regent has acetylcysteine oral and inhalation solution on shortage due to manufacturing delays. They are not currently marketing the 200 mg/mL 30 mL vials.

• 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 • Pfizer has acetylcysteine solution 100 mg/mL 30 mL vials available in limited supply. • 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-July 2020 for the 30 mL vials. The 100 mg/mL 30 mL vials are on back order and the company estimates a release date of late-June 2020.


50% Dextrose Injection June 1, 2020 Reason for 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 available in limited supply.

• 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

25% Dextrose Injection June 1, 2020 Reason for 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

Thiamine Injection June 2, 2020 Reason for 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 < 2 months. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=502


Dobutamine Injection June 2, 2020 Reason for 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 June 2020. There are short-dated 20 mL vials in 1 count available with an expiration date of July 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 Dexmedetomidine Hydrochloride 4mcg/mL Premix for Injection June 2, 2020 Reason for 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-June 2020. The 20 mL vials are on back order and the company estimates a release date of mid-June 2020.

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

• Pfizer has Precedex 4 mcg/mL in 0.9% sodium chloride 50 mL bottles and 20 mL vials available in limited supply.


Ceftazidime Injection June 2, 2020 Reason for 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 available in limited supply.



Cefoxitin Sodium Injection June 2, 2020 Reason for 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.

Estimated Resupply Dates • 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 allocation. • Fresenius Kabi has cefoxitin 2 gram vials on back order and the company estimates a release

date of mid-July 2020. • 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 June 2020. The 1 gram vials are on allocation.


Cefepime Injection June 2, 2020 Reason for shortage

• Apotex has cefepime injection available. • Baxter has cefepime on allocation due to increased demand. • BBraun has cefepime on shortage due to manufacturing delays. • Fresenius Kabi has cefepime injection available. • Meitheal Pharmaceuticals has cefepime injection available • Pfizer has Maxipime on shortage due to manufacturing delays. • Piramal Critical Care has cefepime powder for solution for injection available. • Sagent has cefepime on shortage due to manufacturing delays. • Samson Medical Technologies has cefepime injection available. • Sandoz discontinued cefepime injection in early-2016. • WG Critical Care has cefepime injection available.

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

release date of October 2020. The 1 gram ADD-Vantage vials and 2 gram ADD-Vantage vials are on back order and the company estimates a release date of February 2023.


• Sagent has cefepime 1 gram vials on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=59

Asparaginase Erwinia chrysanthemi June 2, 2020 Reason for 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 available in limited

supply. • 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

Ampicillin Sodium and Sulbactam Sodium Injection June 2, 2020 Reason for 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 available in limited supply. The 1.5 gram and 3 gram ADD-

Vantage vials are available in limited supply. • Sagent has ampicillin sulbactam 1.5 gram vials, 3 gram vials, and 15 gram bulk vials on back

order and the company estimates a release date of June 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


5% Dextrose Injection (PVC-free and DEHP-free) June 2, 2020 Reason for 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 short-dated 5% dextrose in 100 mL and 1,000 mL PVC/DEHP-free bags

available with an expiration date of < 4 months for the 100 mL bags and < 1 month for the 1,000 mL bags.


Testosterone Pellets for Subcutaneous Implantation June 3, 2020 Reason for 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 estimates a release date in August 2020.


Neomycin and Polymyxin B Sulfates Genitourinary Irrigant June 3, 2020 Reason for shortage

• X-Gen has neomycin and polymyxin b sulfates genitourinary irrigant available. • Pfizer has discontinued Neosporin ampules.

Estimated Resupply Dates • Not reported


Hydrocortisone Oral Tablets June 3, 2020 Reason for 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 was due to increase demand.

Estimated Resupply Dates • Greenstone has hydrocortisone 5 mg, 10 mg, and 20 mg tablets in lmited supply and the

company is allocating supplies. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=648


Chloroquine Phosphate Tablets June 3, 2020 Reason for shortage

• Rising did not provide a reason for the shortage. • Sun Pharma is not currently manufacturing chloroquine phosphate tablets.

Estimated Resupply Dates • Rising has chloroquine phosphate 250 mg and 500 mg tablets on allocation.


Sertraline Hydrochloride Oral Solution June 4, 2020 Reason for shortage

• Aurobindo refuses to provide shortage information. • Greenstone has sertraline hydrochloride 20 mg/mL oral solution on back order due to

manufacturing delays. Estimated Resupply Dates

• Greenstone has sertraline hydrochloride 20 mg/mL oral solution on back order and the company estimates a release date of July 2020.


Morphine Injection June 4, 2020 Reason for 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.

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

• 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.

• Hikma did not provide a reason for the shortage. • Piramal Critical Care did not provide a reason for the shortage.

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.

• Hikma has morphine 4 mg/mL 1 mL vials and 10 mg/mL 1 mL vials on allocation. There are short-dated 8 mg/mL 1 mL vial available with an expiration date of < April 2021. There are short-dated Infumorph 10 mg/mL 20 mL ampules and 25 mg/mL 20 mL ampules available with an expiration date of April 2021. Duramorph 0.5 mg/mL 10 mL ampules and 1 mg/mL 10 mL ampules are on back order and the company estimates a release date of late-June to early-July 2020.

• 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.



Metoprolol Injection June 4, 2020 Reason for shortage

• Alvogen has metoprolol injection available. • American Regent is not currently marketing metoprolol injection. • Athenex has metoprolol injection available. • Baxter has metoprolol injection available. • Fosun Pharma has metoprolol injection available. • Fresenius Kabi had metoprolol injection on shortage due to increased demand. • Mylan Institutional acquired metoprolol injection from Sagent. They discontinued metoprolol

injection in March 2018. • Pfizer has metoprolol injection on shortage due to manufacturing delays. They discontinued the

5 mL ampules in December 2019. • Hikma did not provide a reason for the shortage.

Estimated Resupply Dates • Pfizer has metoprolol 1 mg/mL 5 mL Carpuject syringes on back order and the company

estimates a release date of February 2023. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=363

Methotrexate Injection June 4, 2020 Reason for shortage

• Accord has methotrexate injection on back order due to increased demand. • Fresenius Kabi has methotrexate injection available. • Mylan Institutional has methotrexate injection available. • Pfizer has methotrexate injection available. • Teva has methotrexate injection available. • Hikma has methotrexate injection available.



Hydromorphine Hydrochloride Injection June 4, 2020 Reason for shortage

• Akorn has hydromorphone injection available. • 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. • Pfizer has hydromorphone on shortage due to manufacturing delays. The hydromorphone 1

mg/mL 1 mL iSecure syinges and 2 mg/mL 1 mL iSecure syinges were discontinued in February 2020.

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



• 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 to early-July 2020 for the 5 mL vials, and mid-July 2020 for the 50 mL vials.

• Hikma has hydromorphone 2 mg/mL 20 mL vials on allocation. There are short-dated 2 mg/mL 1 mL vials available with an expiration date of < February 2021.

• Pfizer has 10 mg/mL 5 mL vials on back order and the company estimates a release date of July 2020. The 10 mg/mL 1 mL and 10 mL vials available in limited supply. 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 available in limited supply. The 4 mg/mL 1 mL ampules are on back order and the company estimates a release date of January 2021.


Dexmedetomidine Hydrochloride 100mcg/mL Vials for Injection June 4, 2020 Reason for 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

cannot estimate a release date. • Hikma has dexmedetomidine 100 mcg/mL 2 mL vials on allocation. • 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.



Atropine Sulfate Ophthalmic Ointment June 4, 2020 Reason for shortage

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

• Bausch Health has atropine sulfate ointment on back order and the company estimates a release date of early-August 2020.


Venlafaxine Hydrochloride Extended-Release Capsules June 5, 2020 Reason for 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-June 2020.

• Zydus has all venlafaxine extended-release capsules on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=587

Vancomycin Hydrochloride Injection June 5, 2020 Reason for shortage

• Alvogen has vancomycin injection available. • Athenex has vancomycin injection available. • AuroMedics did not provide a reason for the shortage. • Baxter has vancomycin injection available. • Fresenius Kabi has vancomycin injection available. • Hikma did not provide a reason for the shortage. • Mylan Institutional has vancomycin injection available. • Pfizer has vancomycin vials on back order due to manufacturing delays. • Samson Medical Technologies has vancomycin injection available. • Sagent has vancomycin injection on shortage due to manufacturing delays. • Xellia Pharmaceuticals has vancomycin injection and vancomycin premixed bags available.

Estimated Resupply Dates • AuroMedics has vancomycin 1 gram vials on long-term back order and the company cannot

estimate a release date. • Hikma has vancomycin 750 mg vials, 5 gram vials, and 10 gram vials on allocation.


Propofol Emulsin Injection June 5, 2020 Reason for shortage

• Dr. Reddy's has propofol on shortage due to increased demand.


• Fresenius Kabi has Diprivan available but may experience intermittent back order due to increased demand. Check wholesaler for inventory.

• Pfizer has propofol on shortage due to increased demand. • Sagent has propofol on shortage due to increased demand. • Teva has propofol on shortage due to shipping delays related to COVID-19.

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. • Pfizer has propofol 20 mL, 50 mL, and 100 mL vials available in limited supply for direct

shipment only. • Sagent has propofol 20 mL, 50 mL, and 100 mL vials on allocation. • Teva has propofol 20 mL and 100 mL vials on allocation. The 50 mL vials are on back order and

the company estimates a release date of July 2020. There are short-dated 50 mL vials with an expiration date of August 2020.


Prednisone Oral Tablets June 5, 2020 Reason for shortage

• Cadista has all prednisone tablet presentations available. Cadista discontinued the 10 mg tablets in 500 count bottles and the 20 mg tablets in 1000 count bottles.

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

Estimated Resupply Dates • Hikma has prednisone 1 mg tablets in 100 count unit-dose packages, 1 mg tablets in 100 count

and 1000 count bottles, 2.5 mg tablets in 100 count unit-dose packages, 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.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=563 Potassium Acetate Injection June 5, 2020 Reason for shortage

• Pfizer had potassium acetate on shortage due to manufacturing delays. • Exela has potassium acetate on allocation to prevent hoarding.

Estimated Resupply Dates • Exela has potassium acetate 2 mEq/mL 20 mL vials on allocation.


Ondansetron Hydrochloride Injection June 5, 2020 Reason for 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 late-June to early-July 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 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=405

Nalbuphine Injection June 5, 2020 Reason for shortage

• Pfizer has nalbuphine on shortage due to manufacturing delays. 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 December 2020. The 10 mg/mL 10 mL vials are available in limited supply.


Methenamine Hippurate Tablets June 5, 2020 Reason for 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.



Levetiracetam Immediate-Release Tablets June 5, 2020 Reason for shortage

• Accord discontinued levetiracetam immediate-release tablets. • Aurobindo refuses to provide availability information. • Camber did not provide a reason for the shortage. • Eywa has levetiracetam immediate-release tablets available. • 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 500 count bottles are on intermittent back order and the company is releasing supplies as they become available.

• 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.


Fluticasone Propionate Oral Inhalers June 5, 2020 Reason for 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.



Enoxaparin Sodium Injection June 5, 2020 Reason for shortage

• Amphastar has enoxaparin available. • Apotex has enoxaparin available. • Fresenius Kabi has enoxaparin available. Fresenius Kabi updated NDC numbers of the 80 mg and

100 mg prefilled syringes in October 2019. • Sanofi-Aventis did not provide a reason for the shortage. • Teva has enoxaparin available. • Winthrop has enoxaparin available.

Estimated Resupply Dates • Sanofi-Aventis has Lovenox 120 mg/0.8 mL available with short expiration dating. Lovenox 60

mg/0.6 mL prefilled syringes are on intermittent back order and the company estimates product will be allocated in mid-June 2020.


Bupivacaine Injection June 5, 2020 Reason for 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 on back order and the company estimates a release date of June 2020.

• Pfizer has 0.25% Marcaine 50 mL vials available in limited supply. The 0.5% Marcaine 30 mL preservative-free vials are available in limited supply. The 0.5% 50 mL vials are available in limited supply.


Sufentanil Injection June 8, 2020 Reason for shortage

• Akorn had Sufenta injection on shortage due to increased demand for the product. • Hikma stopped marketing sufentanil injection in October 2018. • Pfizer has sufentanil injection on shortage due to manufacturing delays.



• Akorn has Sufenta 0.5 mg/mL 1 mL, 2 mL, and 5 mL ampules on back order and the company estimates a release date of mid-June 2020.

• Pfizer has sufentanil 0.5 mg/mL 5 mL vials on back order and the company estimates a release date of November 2020. The 1 mL and 2 mL vials are on back order and the company estimates a release date of February 2021.


Sterile Water for Injection- Small Volume Vials June 8, 2020 Reason for 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 vials available with short expiration

dating. The 20 mL vials are on back order and the company cannot estimate a release date. • 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 2021. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=375

Sertraline Oral Tablets June 8, 2020 Reason for shortage

• Accord is unable to obtain active pharmaceutical ingredient to manufacture sertraline due to effects of COVID-19.

• 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 has product on shortage due to increased demand and lack of supply of the active

pharmaceutical ingredient. • Pfizer currently has enough product to supply historical demand.

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-count bottles on back order and the company cannot

estimate a release date. The company has partial lots available of 25 mg tablets in 90-count bottles and 50 mg tablets in 500-count bottles.

• Exelan Pharmaceuticals has sertraline 25 mg tablets in 100-count bottles, 50 mg tablets in 90- and 180-count bottles, and 100 mg tablets in 180- and 500-count bottles on back order and the company estimates a release date of June 2020. The 100 mg tablets in 90-count bottles are on back order and the company cannot estimate a release date.

• 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.



Secobarbital Capsules June 8, 2020 Reason for shortage

• Bausch Health is the sole supplier of secobarbital capsules. The company states that Seconal capsules are on back order due to a short-term stock out.

Estimated Resupply Dates • Bausch Health has Seconal (secobarbital) 100 mg capsules on back order and the company

cannot estimate a release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=517

Rocuronium Injection June 8, 2020 Reason for 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 allocation. • 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 early-July 2020. • Hikma has rocuronium 10 mg/mL 5 mL and 10 mL vials on back order and the company

estimates a release date of mid-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

estimates a release date of mid-June 2020.


Multipl Vitamins for Infusion June 8, 2020 Reason for shortage

• Pfizer states the shortage is due to manufacturing delays. • Baxter has all presentations fully available at this time.

Estimated Resupply Dates • Baxter has Infuvite 100 mL vials available in limited supply. • Pfizer has M.V.I. Adult 2 X 5 mL Dual vials, M.V.I. Adult 2 X 50 mL vials, and Pediatric 5 mL vials

on back order and the company estimates a release date of September 2021. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=69

Leucovorin Calcium Injection June 8, 2020 Reason for 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 early- to mid-June 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 50 mg vials on back order and the company estimates a release date of late-July 2020. The 350 mg vials are on allocation.

• 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.


Echothiophate Iodide Ophthalmic Drops June 8, 2020 Reason for shortage

• Pfizer has Phospholine Iodide ophthalmic drops on shortage due to manufacturing delays. • Pfizer is the sole supplier of echothiophate iodide.

Estimated Resupply Dates • Pfizer has Phospholine Iodide 6.25 mg/5 mL ophthalmic drops on back order and the company

estimates a release date of July 2020. There are limited short-dated bottles with an expiration date of August 2020.


Dorzolamide 2% and Timolol 0.5% Ophthalmic Solution June 8, 2020 Reason for shortage

• Akorn has dorzolamide and timolol ophthalmic solution available. • Sandoz did not provide a reason for the shortage. • Teva discontinued dorzolamide and timolol ophthalmic solution in April 2018.


• Bausch Health had dorzolamide and timolol ophthalmic solution on shortage due to manufacturing delays.

Estimated Resupply Dates • Akorn has dorzolamide/timolol 2%/0.5% ophthalmic solution in 10 mL bottles on allocation. • Sandoz has dorzolamide/timolol 2%/0.5% ophthalmic solution in 10 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=360

Diltiazem Hydrochloride Injection June 8, 2020 Reason for 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. • Hilkma 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 vials on back order and the company estimates a release date of July 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

23.4% Sodium Chloride Injection June 8, 2020 Reason for 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 to early-July

2020. • The 200 mL (NDC 63323-0088-63) vials have an estimated release date of mid-July 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

Gentamicin Injection June 9, 2020 Reason for shortage

• Baxter has gentamicin premixes available. • Fresenius Kabi did not provide a reason for the shortage.


• Pfizer has gentamicin on shortage due to manufacturing delays. Estimated Resupply Dates

• Fresenius Kabi has gentamicin 40 mg/mL 2 mL vials on back order and the company estimates a release date of late-June 2020.

• Pfizer has gentamicin 40 mg/mL 2 mL vials on back order and the company estimates a release date of June 2020.


Furosemide Injection June 9, 2020 Reason for 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 intermittent back order and the company is releasing product as it becomes available.

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

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


Diphenhydramine Injection June 9, 2020 Reason for shortage

• Armas Pharmaceuticals has diphenhydramine injection available. • Fresenius Kabi has diphenhydramine injection available. • Hikma has diphenhydramine injection available. • Mylan has diphenhydramine injection available. • Pfizer has dipehnhydramine injection on shortage due to manufacturing delays.

Estimated Resupply Dates • Pfizer has diphenhydramine 50 mg/mL 1 mL vials on 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=456

Bivalirudin Injection June 9, 2020 Reason for 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 did not provide a reason for the shortage. • Fresenius Kabi has bivalirudin available. • Pfizer has bivalirudin available. • Sandoz has bivalirudin available.

Estimated Resupply Dates • Dr. Reddy's has bivalirudin 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=569

Ethambutol Tablets June 10, 2020 Reason for shortage

• Lupin did not provide a reason for the shortage. • STI Pharma did not provide a reason for the shortage. • Teva has ethambutol tablets available. • X-Gen has Myambutol tablets available.

Estimated Resupply Dates • STI Pharma has ethambutol 400 mg tablets on back order and the company estimates a release

date in early-June 2020. • Lupin has ethambutol 100 mg and 400 mg tablets on back order and the company estimates

release dates of late-June to early-July 2020 for the 100 mg tablets and mid-June 2020 for the 400 mg tablets.


Valproate Sodium Injection June 11, 2020 Reason for shortage

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



Testosterone Cypionate Injection June 11, 2020 Reason for 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.



• 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 10 mL vials on allocation. The 1 mL vials are on back order and the company estimates a release date of late-June 2020.

• 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.


Mineral Oil and Petrolatum Ophthalmic Ointment June 11, 2020 Reason for 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 estimates a release

date in early-July 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=435

Iothalamate Meglumine Injection June 11, 2020 Reason for 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 50 mL vials on back order and the company estimates a release date

in July 2020. The 30 mL vials and 150 mL bottles are on back order and the company estimates release dates in early-September 2020.


Hydralazine Injection June 11, 2020 Reason for shortage

• Akorn did not provide a reason for the shortage. • American Regent is not currently marketing hydralazine injection. • Fresenius Kabi has hydralazine available. • X-Gen did not provide a reason for the shortage.

Estimated Resupply Dates • Akorn has hydralazine 20 mg/mL 1 mL vials on back order and the company estimates a release

date of August 2020.


• X-Gen has hydralazine 20 mg/mL 1 mL vials on back order and the company cannot estimate a release date.


Epinephrine Auto-Injectors June 11, 2020 Reason for 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 mid-June 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=420

Calcium Acetate Oral Capsules and Tablets June 11, 2020 Reason for shortage

• Amneal discontinued calcium acetate capsules in January 2020. • Chartwell has calcium acetate capsules available. • Cipla has calcium acetate capsules temporarily unavailable. • Hikma did not provide a reason for the shortage. • Avet (previously Heritage) did not provide a reason for the shortage. • Major did not provide a reason for the shortage. • Marlex did not provide a reason for the shortage. • Nephro-Tech has Calphron tablets available. • Nostrum has calcium acetate capsules temporarily unavailable. • Perrigo has temporarily discontinued calcium acetate tablets. The company cannot estimate a

relaunch date. • Sandoz has calcium acetate capsules available.

Estimated Resupply Dates • Avet has calcium acetate capsules and tablets on back order and the company cannot estimate a

release date. • Hikma has calcium acetate capsules on allocation. • Major has calcium acetate capsules on back order and the company estimates a release date in

early-July 2020. • Marlex has calcium acetate capsules on back order and the company cannot estimate a release

date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=617


Bumetanide Injection June 11, 2020 Reason for 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 on back order and the company estimates a

release date of mid-June 2020. The 10 mL vials are on allocation. • Pfizer has bumetanide 0.25 mg/mL 4 mL and 10 mL vials 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=307

Amyl Nitrite Inhalation June 11, 2020 Reason for 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 estimates a release date in late-June 2020.


Valsartan and Hydrochlorothiazide Tablets June 12, 2020 Reason for 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 probably 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. • Macleods did not provide a reason for the shortage. • 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. • Macleods has valsartan/hydrochlorothiazide tablets on back order and the company estimates a

release date in late-June to early-July 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=445


Telmisartan Tablets June 12, 2020 Reason for 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 estimates a

release date in mid-July 2020. • 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.


Sulfasalazine Enteric-Coated and Immediate-Release Tablets June 12, 2020 Reason for shortage

• Greenstone did not provide a reason for the shortage. • Teva did not provide a reason for the shortage. • Pfizer has Azulfidine Entabs on back order due to manufacturing delays.

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.

• Pfizer has Azulfidine Entabs 500 mg coated tablets in 100 count on back order and the company estimates a release date in July 2020.

• 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.


Simethicone Oral Liquid June 12, 2020 Reason for 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 has simethicone oral suspension available.

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 late-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-June 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. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=632

Meperidine Hydrochloride Injection June 12, 2020 Reason for shortage

• Pfizer has Demerol injection on shortage due to manufacturing delays. • ICU Medical discontinued meperidine 30 mL PCA vials.

Estimated Resupply Dates • Hikma has meperidine 25 mg/mL 1 mL vials on allocation. The 50 mg/mL 1 mL vials and 100

mg/mL 1 mL vials are on back order and the company estimates a release date of late-June to early-July 2020 for the 50 mg/mL 1 mL vials and early-July 2020 for the 100 mg/mL vials.

• Pfizer has Demerol 75 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of July 2020. The 100 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of November 2020. The 50 mg/mL 0. 5 mL and 1 mL ampules and 100 mg/mL 1 mL ampules are on back order and the company estimates a release date of February 2023. The 50 mg/mL 1.5 mL ampules are on back order and the company estimates a release date of August 2020. The 100 mg/mL 20 mL vials are on back order and the company estimates a release date of June 2020.


Immune Globulin, Intravenous or Subcutaneous (Human) June 12, 2020 Reason for 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 Cutaquig, Octagam, and Panzyga 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 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

Sodium Phosphate Injection June 15, 2020 Reason for shortage

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

Estimated Resupply Dates • Pfizer has sodium phosphate 3 mmol/mL 15 mL 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=227

Nizatidine Capsules June 15, 2020 Reason for shortage

• Glenmark discontinued nizatidine capsules • Mylan discontinued nizatidine capsules. • Teva did not provide a reason for the shortage.

Estimated Resupply Dates • Teva has nizatidine capsules on back order and the company cannot estimate a release date.


Lidocaine with Epinephrine Injection June 15, 2020 Reason for 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 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 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


Lidocaine Injection June 15, 2020 Reason for 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 • Hikma has 1% lidocaine 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.


Cafotaxime Sodium Injection June 15, 2020 Reason for shortage

• Hospira has discontinued Claforan. Sanofi-Aventis manufactured Claforan for Hospira and is no longer making the product.

• Baxter discontinued Claforan in late-2015. • Hikma is not currently marketing cefotaxime injection.

Estimated Resupply Dates • Apollo Pharmaceuticals is temporarily importing cefotaxime 1 gram and 2 gram vials.


Bupivacaine wirh Epinephrine Injection June 15, 2020 Reason for 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 late-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-June 2020. The 0.5% Sensorcaine-MPF with epinephrine 10 mL vials are on back order and the company estimates a release date of late-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-June 2020. The 0.5% Sensorcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of late-June 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.


Azithromycin Injection June 15, 2020 Reason for 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-June 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.


Atropine Sulfate Injection June 15, 2020 Reason for 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.

Estimated Resupply Dates • American Regent has atropine 0.4 mg/mL 1 mL vials available in limited supply. • Amphastar has atropine 0.1 mg/mL 10 mL syringes on allocation. • Hikma has atropine 0.4 mg/mL 20 mL vials on back order and the company estimates a release

date of late-June to early-July 2020. • 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. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=46

Amiodarone Injection June 15, 2020 Reason for 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.

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 allocation. • Fresenius Kabi has amiodarone 50 mg/mL 3 mL and 9 mL vials on back order and the company

estimates a release date of mid-July 2020 for the 3 mL vials and late-June to early-July 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 late-July 2020.

• Mylan Institutional has amiodarone 50 mg/mL 3 mL, 9 mL, and 18 mL vials on back order and the company estimates a release date of late-July 2020 for the 3 mL vials and mid-July 2020 for the 9 mL vials.


Aminocaproic Acid Injection June 15, 2020 Reason for shortage

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




Tobramycin Sulfate Lyophilized Powder for Solution June 17, 2020 Reason for 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 early-July 2020. Check wholesalers for inventory. • X-Gen has tobramycin 1.2 gram vials on allocation.


Tacrolimus Capsules June 17, 2020 Reason for 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 and 5 mg capsules on allocation. • Sandoz has tacrolimus 0.5 mg, 1 mg, and 5 mg capsules in 100 count on intermittent back order

and the company is allocating product upon release. • Strides has tacrolimus 1 mg capsules on allocation.


Midazolam Injection June 17, 2020 Reason for 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-

June 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 on back order and the company estimates a release date of late-July 2020. The 1 mg/mL 5 mL vials are on back order and the company estimates a release date of mid-June 2020. The 5 mg/mL 1 mL vials are on back order and the company estimates a release date of late-June to early-July 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 5 mL vials on back order and the company estimates a release date of late-July 2020. The 5 mg/mL 1 mL and 2 mL vials are on back order and the company estimates a release date of late-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. 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 July 2020. The 5 mg/mL 10 mL vials are available in limited supply.


Magnesium Sulfate Injection June 17, 2020 Reason for 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

• Exela has 500 mg/mL 10 mL vials available for direct orders only. • 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-June 2020. There are short-dated 80 mg/mL 50 mL premixed bags available with an expiration date of <4 months. There are short-dated 500 mg/mL 2 mL vials with an expiration date of <8 months. The 500 mg/mL 50 mL vials are on back order and the company cannot estimate a release date.

• Pfizer has magnesium sulfate 500 mg/mL 20 mL vials on back order and the company estimates a release date of February 2023. The 500 mg/mL 10 mL syringes are on back order and the company estimates a release date of June 2020.

• WG Critical Care has 40 mg/mL 50 mL premixed bags on intermittent back order with weekly releases.



Deferoxamine Injection June 17, 2020 Reason for 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 deferoxamine 2 gram vials on back order and the company cannot estimate a

release date. • Fresenius Kabi has deferoxamine 2 gram 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=393

Cisatracurium Besylate Injection June 17, 2020 Reason for 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 had 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.

Estimated Resupply Dates • Fresenius Kabi has cisatracurium 2 mg/mL 5 mL vials on back order and the company estimates

a release date of late-June to early-July 2020. The 2 mg/mL 10 mL vials and 10 mg/mL 20 mL vials are on back order and the company cannot estimate a release date. Check wholesalers for inventory.

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

• Pfizer has cisatracurium 10 mg/mL 20 mL vials available in limited supply. The 2 mg/mL 5 mL vials are on back order and the company estimates a release date of October 2020. The 2 mg/mL 10 mL vials are 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 all Nimbex 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=652


*Please refer to ASHP website for more information at: https://www.ashp.org/Drug-Shortages/Current-Shortages

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