FDA recall D-0595-2018

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2018-01-19

Report date

2018-02-21

Termination date

2019-03-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

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