Drug product
Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
D-0793-2022
Product summary
- Event
- Event 90029
- Status
- Completed
- Classification
- Class II
- Quantity
- a) 7,044 bottles; b) 1,014 bottles
- Official record key
drug-enforcement:D-0793-2022
Official wording
Reason: cGMP deviations
Code information: a) Lot #: 29200053, Exp 4/30/2023; b) Lot #: 29200054, Exp 4/30/2023
Distribution pattern: USA nationwide
Derived failure modes
-
Manufacturing or process control
cGMP deviations