Home / Recalls / Direct Rx / D-0829-2021

D-0829-2021 Class II Terminated

Recalled by Direct Rx — Dawsonville, GA

Recall Details

Product Type
Drugs
Report Date
September 29, 2021
Initiation Date
September 14, 2021
Termination Date
October 22, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 bottles

Product Description

Zonisamide 100 mg Capsules, 30-count bottles, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-0775-30

Reason for Recall

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

Distribution Pattern

FL only

Code Information

Lot #: 17JU2118 Exp. 5/31/23

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