Drug product
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
D-0314-2024
Product summary
- Event
- Event 93918
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,932 cartons
- Official record key
drug-enforcement:D-0314-2024
Official wording
Reason: CGMP Deviations
Code information: Lot # 1015033, exp. 06/30/2025; 1016409, exp. 08/31/2025
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations