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

FDA recall notice · announced February 14, 2024 · Amerisource Health Services

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

CGMP Deviations

Notes

Distribution: USA Nationwide
Lot/code information: Lot # 1015033, exp. 06/30/2025; 1016409, exp. 08/31/2025
Quantity: 1,932 cartons
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.