D-0595-2018 Class II Terminated

Recalled by AMERICAN HEALTH PACKAGING — Columbus, OH

Recall Details

Product Type
Drugs
Report Date
February 21, 2018
Initiation Date
January 19, 2018
Termination Date
March 14, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
270 cartons

Product Description

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.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 174096, Exp 05/31/19