Product: 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.
Recall initiated: 20220513
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated