D-0793-2022 Class II
Recall Details
- Product Type
- Drugs
- Report Date
- May 4, 2022
- Initiation Date
- April 25, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 7,044 bottles; b) 1,014 bottles
Product Description
Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Reason for Recall
cGMP deviations
Distribution Pattern
USA nationwide
Code Information
a) Lot #: 29200053, Exp 4/30/2023; b) Lot #: 29200054, Exp 4/30/2023