Drug product
Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
D-0821-2021
Product summary
- Event
- Event 88591
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9552 bottles
- Official record key
drug-enforcement:D-0821-2021
Official wording
Reason: CGMP Deviations
Code information: Lots: 29190087 Exp. 10/31/2021; 29190088 Exp. 10/31/2021; 29190089 Exp. 10/31/2021; 29200077 Exp. 11/30/2022; 29200078 Exo, 11/30/2022
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations