D-0791-2022 Class II
FDA drug recall D-0791-2022 was initiated by Glenmark Pharmaceuticals Inc., USA on Apr 25, 2022 and is designated Class II. Reason for recall: cGMP deviations Affected quantity: 11,136 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 4, 2022
- Initiation Date
- Apr 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,136 bottles
Product Description
Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-128-01
Reason for Recall
cGMP deviations
Distribution Pattern
USA nationwide
Code Information
Lot #: 29200052, 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-0791-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026