Drug product
Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-128-01
D-0791-2022
Product summary
- Event
- Event 90029
- Status
- Completed
- Classification
- Class II
- Quantity
- 11,136 bottles
- Official record key
drug-enforcement:D-0791-2022
Official wording
Reason: cGMP deviations
Code information: Lot #: 29200052, Exp 4/30/2023
Distribution pattern: USA nationwide
Derived failure modes
-
Manufacturing or process control
cGMP deviations