Drug recall D-0821-2021

Class II Terminated reported Sep 29, 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

Reason for recall

CGMP Deviations

Lots and codes

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

Recall details

Recalling firm
Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
Quantity
9552 bottles
Distribution
Nationwide.
Type
Voluntary: Firm initiated
Recall initiated
August 27, 2021
Terminated
October 4, 2023

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