Presentation #18

Drug Recalls

Drug Recalls

• Drug recalls must be reviewed by the Department and forwarded to the appropriate manager at the LHD.

• The manager shall arrange for removal of a recalled drug and return it to the manufacturer in accordance with the recall instructions

Drug Recalls

• A copy of the recall letter must be returned to the Department with either. . .

- Documentation that no such product is on site.

-Documentation that the product was returned to the supplier.

Drug Recalls• Notation of a recall must also be made

on the Drug Inventory Log and retained for a minimum of five years

• In the event of a Class I (patient level) Recall, the manager must contact all patients that received the affected lot

- The records documenting contact with patients and returns shall be maintained on-site for at least two years following recall.