Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton...
FDA Recall #D-0454-2025 — Class II — May 15, 2025
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
Recalling Firm
Amerisource Health Services LLC — Columbus, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
21 cartons
Distribution
Nationwide in the USA
Code Information
Lot #: 1021950, Exp. 11/30/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated