FDA Recall Penicillin V Potassium

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Penicillin V Potassium with NDC 0093-1174 was initiated on 03-15-2021 as a Class II recall due to cgmp deviations: intermittent exposure to temperature excursion during storage. The latest recall number for this product is D-0576-2021 and the recall is currently completed .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-0576-202103-15-202106-02-2021Class II91 bottlesPENICILLIN V POT for Oral Solution, USP 125mg/5mL 100mL (when mixed) Rx Only, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4125-73Completed
D-0108-201811-28-201712-20-2017Class III42,384 bottlesPenicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454; NDC 0093-4125-73.Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.