Aripiprazole Tablets recalled over manufacturing violations
- Recall date
- January 19, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- AMERICAN HEALTH PACKAGING recalls Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11…
- Recall number
- D-0595-2018
- FDA classification
- Class II
- Brand / firm
- AMERICAN HEALTH PACKAGING
- Sold / distributed
- Nationwide in the USA
Why it was recalled
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7] per carton (NDC 60687-179-01), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217.
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