Product: Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 100 Capsules NDC 68462-130-01; b) 500 Capsules NDC 68462-130-05
Reason for recall: CGMP Deviations
Recall initiated: 20210827
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated