Recall: D-0595-2018

Class II - Potentially Harmful

Class IIClassification

2018-01-19Initiated

TerminatedStatus

AMERICAN HEALTH PACKAGINGFirm

Product

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.

Reason

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.