D-0454-2025Class II

Amerisource Health Services LLC

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2025-06-11

Distribution

Nationwide in the USA

Firm state

Product quantity

21 cartons

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Risk Management & CAPA

Reason for recall

cGMP deviations

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).

Code / lot info

Lot #: 1021950, Exp. 11/30/2026

Other recalls SPEQ maps to Risk Management & CAPA

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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.