Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Heal...
FDA Recall #D-0314-2024 — Class II — January 25, 2024
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
Recalling Firm
Amerisource Health Services LLC — Columbus, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1,932 cartons
Distribution
USA Nationwide
Code Information
Lot # 1015033, exp. 06/30/2025; 1016409, exp. 08/31/2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated