Drug product
LYRICA (pregabalin) capsules, 200mg 90-count bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, MADE IN SINGAPORE
D-0552-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49 bottles
- Official record key
drug-enforcement:D-0552-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: CK1081
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations