FDA recall D-0454-2025

Amerisource Health Services LLC · Class II · drug

Product

Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton), NDC 68084-411-11 (blister card).

Reason for recall

cGMP deviations

Distribution

Nationwide in the USA

Key facts

Status: Ongoing
Initiation date: 2025-05-15
Report date: 2025-06-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0454-2025