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

Recall Number: D-0826-2021

Firm: Glenmark Pharmaceuticals Inc., USA

Classification: Class II

Status: Terminated

Report Date: 20210929

Initiation Date: 20210827

Termination Date: 20231004

CGMP Deviations

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