Drug product
Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30
D-0829-2021
Product summary
- Firm
- Direct Rx
- Event
- Event 88749
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 bottles
- Official record key
drug-enforcement:D-0829-2021
Official wording
Reason: CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Code information: Lot #: 17JU2118 Exp. 5/31/23
Distribution pattern: FL only
Derived failure modes
-
Manufacturing or process control
CGMP deviations