Why it was recalled
CGMP Deviations
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
Lot numbers, UPCs & expiration codes
Lot # 1015033, exp. 06/30/2025; 1016409, exp. 08/31/2025
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0314-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 25, 2024
- FDA report date
- Feb 14, 2024
- Quantity
- 1,932 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerisource Health Services LLC
Original FDA data
Every field from FDA enforcement report D-0314-2024, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 93918
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot # 1015033, exp. 06/30/2025; 1016409, exp. 08/31/2025
- Postal code
- 43217-1188
- Report date
- Feb 14, 2024
- Product type
- Drugs
- Recall number
- D-0314-2024
- Classification
- Class II
- Recalling firm
- Amerisource Health Services LLC
- Product quantity
- 1,932 cartons
- Termination date
- Dec 22, 2025
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jan 25, 2024
- Initial firm notification
- Letter
- Center classification date
- Feb 6, 2024