Drug product
Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90
D-0888-2022
Product summary
- Firm
- Direct Rx
- Event
- Event 90215
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16 bottles
- Official record key
drug-enforcement:D-0888-2022
Official wording
Reason: CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Code information: Lot: 23JY2124 Exp. 6/30/23
Distribution pattern: Nationwide to the U.S. market
Derived failure modes
-
Manufacturing or process control
CGMP Deviations