Drug recall D-0822-2021
Product
Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Tablets NDC 68462-179-01; b) 500 Tablets NDC 68462-179-05
Reason for recall
CGMP Deviations
Lots and codes
Lots: a) 29190082 Exp. 09/30/2021; 29190083 Exp. 09/30/2021; 29190084 Exp. 10/31/2021; 29190085 Exp. 10/31/2021; 29200001 Exp. 12/31/2021; 29200003 Exp. 01/31/2022; 29200004 Exp. 01/31/2022; 29200005 Exp. 01/31/2022; 29200012 Exp. 02/28/2022; 29200013 Exp. 02/28/2022; b) 29200010 Exp. 02/28/2022
Recall details
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Quantity
- a) 31248 bottles; b) 300 bottles
- Distribution
- Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 27, 2021
- Terminated
- October 4, 2023
Related products
- Naproxen Sodium – drug information
- NDC 68462-179 Naproxen Sodium · Naproxen Sodium 550 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-178 Naproxen Sodium · Naproxen Sodium 275 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-189 Naproxen · Naproxen 375 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-188 Naproxen · Naproxen 250 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-190 Naproxen · Naproxen 500 mg/1 · Glenmark Pharmaceuticals Inc., USA