FDA recall D-0314-2024

Amerisource Health Services LLC · Class II · drug

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

Reason for recall

CGMP Deviations

Distribution

USA Nationwide

Key facts

Status
Terminated
Initiation date
2024-01-25
Report date
2024-02-14
Termination date
2025-12-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0314-2024