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

Recall Number: D-0888-2022

Firm: Direct Rx

Classification: Class II

Status: Terminated

Report Date: 20220601

Initiation Date: 20220513

Termination Date: 20240930

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

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