FDA-Drug2018-02-21Class II

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.

AMERICAN HEALTH PACKAGING
Hazard

CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.

Sold states
Nationwide in the USA
Affected count
270 cartons
Manufactured in
2550 John Glenn Ave Ste A, Columbus, OH, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0595-2018

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