Drug product
Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (NDC 00093-4125-74) (when mixed) bottles, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454
D-0294-2022
Product summary
- Event
- Event 89255
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 86,790 and b) 25,416 bottles
- Official record key
drug-enforcement:D-0294-2022
Official wording
Reason: Subpotent
Code information: a) Lots, 35446365A, Exp 03/2022; 35447040A, Exp 08/2022 & 35447948B, Exp 03/2023. b) Lots 35446318B, Exp 05/2022 & 35447947A, Exp 03/2023.
Distribution pattern: nationwide
Derived failure modes
-
Potency or specification failure
Subpotent