D-0314-2024 Class II Terminated
FDA drug recall D-0314-2024 was initiated by Amerisource Health Services LLC on Jan 25, 2024 and is designated Class II. Reason for recall: CGMP Deviations The recall status is terminated (terminated Dec 22, 2025). Affected quantity: 1,932 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 14, 2024
- Initiation Date
- Jan 25, 2024
- Termination Date
- Dec 22, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,932 cartons
Product Description
Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-538-21, NDC Unit dose 60687-538-11
Reason for Recall
CGMP Deviations
Distribution Pattern
USA Nationwide
Code Information
Lot # 1015033, exp. 06/30/2025; 1016409, exp. 08/31/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0314-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026