Drug product
PENICILLIN V POT for Oral Solution, USP 125mg/5mL 100mL (when mixed) Rx Only, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4125-73
D-0576-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 91 bottles
- Official record key
drug-enforcement:D-0576-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 35446365A
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations