D-0314-2024Class II

Amerisource Health Services LLC

Recalling firm

Product type

Drug

Status

Terminated

Report date

2024-02-14

Distribution

USA Nationwide

Firm state

Product quantity

1,932 cartons

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Risk Management & CAPA

Reason for recall

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

Code / lot info

Lot # 1015033, exp. 06/30/2025; 1016409, exp. 08/31/2025

Other recalls SPEQ maps to Risk Management & CAPA

2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.

See all Risk Management & CAPA recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.