Drug recall D-0825-2021

Class II Terminated reported Sep 29, 2021

Product

Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

Reason for recall

CGMP Deviations

Lots and codes

Lots: 29190043 Exp. 05/31/2022; 29190044 Exp. 05/31/2022; 29190045 Exp. 05/31/2022

Recall details

Recalling firm
Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
Quantity
15936 bottles
Distribution
Nationwide.
Type
Voluntary: Firm initiated
Recall initiated
August 27, 2021
Terminated
October 4, 2023

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