D-0888-2022 Class II Terminated
FDA drug recall D-0888-2022 was initiated by Direct Rx on May 13, 2022 and is designated Class II. Reason for recall: CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory. The recall status is terminated (terminated Sep 30, 2024). Affected quantity: 16 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 1, 2022
- Initiation Date
- May 13, 2022
- Termination Date
- Sep 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16 bottles
Product Description
Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 61919-775-90
Reason for Recall
CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
Distribution Pattern
Nationwide to the U.S. market
Code Information
Lot: 23JY2124 Exp. 6/30/23
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0888-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026