Recalls / Class II
Class IID-0314-2024
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
- Brand name
- Febuxostat
- Generic name
- Febuxostat
- Active ingredient
- Febuxostat
- Route
- Oral
- NDC
- 60687-538
- FDA application
- ANDA205467
- Affected lot / code info
- Lot # 1015033, exp. 06/30/2025; 1016409, exp. 08/31/2025
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Amerisource Health Services LLC
- Manufacturer
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 1,932 cartons
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2024-01-25
- FDA classified
- 2024-02-06
- Posted by FDA
- 2024-02-14
- Terminated
- 2025-12-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0314-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.