Drug recall D-0595-2018

Class II Terminated reported Feb 21, 2018

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 for recall

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

Lots and codes

Lot #: 174096, Exp 05/31/19

Recall details

Recalling firm
AMERICAN HEALTH PACKAGING, Columbus, OH
Quantity
270 cartons
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
January 19, 2018
Terminated
March 14, 2019

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