Indomethacin Extended-Release Capsules recalled over manufacturing violations
- Recall date
- May 15, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Amerisource Health Services LLC recalls Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed…
- Recall number
- D-0454-2025
- FDA classification
- Class II
- Brand / firm
- Amerisource Health Services LLC
- Sold / distributed
- Nationwide in the USA
Why it was recalled
cGMP deviations
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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).
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