D-0595-2018 Class II Terminated
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