Drug product
PREGABALIN CAPSULES 300MG 90 ; NDC 43598-298-90; RX; CAPSULES
D-0469-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 CONTAINERS
- Official record key
drug-enforcement:D-0469-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: T2000309
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations