Drug product
Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
D-0825-2021
Product summary
- Event
- Event 88591
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15936 bottles
- Official record key
drug-enforcement:D-0825-2021
Official wording
Reason: CGMP Deviations
Code information: Lots: 29190043 Exp. 05/31/2022; 29190044 Exp. 05/31/2022; 29190045 Exp. 05/31/2022
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations