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
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Classification
Class II
Status
Terminated
Lot
Lot #: 17JU2118 Exp. 5/31/23
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.