Product: 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.
Recall initiated: 20210914
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated