Recalls / Class II
Class IID-0821-2021
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
- Brand name
- Naproxen Sodium
- Generic name
- Naproxen Sodium
- Active ingredient
- Naproxen Sodium
- Route
- Oral
- NDCs
- 68462-178, 68462-188, 68462-189, 68462-190, 68462-179
- FDA application
- ANDA078314
- Affected lot / code info
- 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
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 9552 bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2021-08-27
- FDA classified
- 2021-09-21
- Posted by FDA
- 2021-09-29
- Terminated
- 2023-10-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0821-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.