D-0793-2022 Class II
FDA drug recall D-0793-2022 was initiated by Glenmark Pharmaceuticals Inc., USA on Apr 25, 2022 and is designated Class II. Reason for recall: cGMP deviations Affected quantity: a) 7,044 bottles; b) 1,014 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 4, 2022
- Initiation Date
- Apr 25, 2022
- 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0793-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026