PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: February 14, 2024 Initiated: January 25, 2024 #D-0314-2024

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

Details

Units Affected
1,932 cartons
Distribution
USA Nationwide
Location
Columbus, OH

Frequently Asked Questions

What product was recalled?
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. Recalled by Amerisource Health Services LLC. Units affected: 1,932 cartons.
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on February 14, 2024. Severity: Moderate. Recall number: D-0314-2024.