Febuxostat Tablet, Film Coated
FDA Recall NDC 60687-538
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Febuxostat (NDC 60687-538). A significant event, classified as Class II, was initiated on Jan 25, 2024 by American Health Packaging. The reported reason for this action was: "CGMP Deviations"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations
Jan 25, 2024
Feb 14, 2024
1,932 cartons
Recall Profile & Regulatory Data
Event ID
93918
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Amerisource Health Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Dec 22, 2025
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
Batch or Lot Expiration Information
Lot# 1015033, exp. 06/30/2025; 1016409, exp. 08/31/2025
Affected Packages Involved in this Recall
60687-538-11Product
60687-538-21Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
