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

Recall Number: D-0829-2021

Firm: Direct Rx

Classification: Class II

Status: Terminated

Report Date: 20210929

Initiation Date: 20210914

Termination Date: 20211022

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

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