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.

FDA recall notice · announced February 21, 2018 · American Health Packaging

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot #: 174096, Exp 05/31/19
Quantity: 270 cartons
Status: Terminated
Products in this recall event:
- 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 Packag (D-0595-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.