Drug product
Verapamil Hydrochloride Extended-Release Tablets USP 120 mg Rx Only NDC 68462-292-01 Manufactured by: Glenmark Generics Ltd Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Generics Inc., USA Mahwah, NJ 07430
D-0483-2021
Product summary
- Event
- Event 87512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 513 bottles
- Official record key
drug-enforcement:D-0483-2021
Official wording
Reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Code information: 19205584
Distribution pattern: FL, GA, SC
Derived failure modes
-
Manufacturing or process control
CGMP Deviations