D-0454-2025 Class II Ongoing
FDA drug recall D-0454-2025 was initiated by Amerisource Health Services LLC on May 15, 2025 and is designated Class II. Reason for recall: cGMP deviations The recall status is ongoing. Affected quantity: 21 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- June 11, 2025
- Initiation Date
- May 15, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 cartons
Product Description
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 Pattern
Nationwide in the USA
Code Information
Lot #: 1021950, Exp. 11/30/2026