Drug product
Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
D-0823-2021
Product summary
- Event
- Event 88591
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1800 bottles
- Official record key
drug-enforcement:D-0823-2021
Official wording
Reason: CGMP Deviations
Code information: Lots: 29200022 Exp. 03/31/2022; 29200024 Exp. 03/31/2022; 29200035 Exp. 06/30/2022
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations