Home / Recalls / Direct Rx / D-0888-2022

D-0888-2022 Class II Terminated

Recalled by Direct Rx — Dawsonville, GA

Recall Details

Product Type
Drugs
Report Date
June 1, 2022
Initiation Date
May 13, 2022
Termination Date
September 30, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16 bottles

Product Description

Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90

Reason for Recall

CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.

Distribution Pattern

Nationwide to the U.S. market

Code Information

Lot: 23JY2124 Exp. 6/30/23

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