Drug 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.
D-0595-2018
Product summary
- Event
- Event 79036
- Status
- Terminated
- Classification
- Class II
- Quantity
- 270 cartons
- Official record key
drug-enforcement:D-0595-2018
Official wording
Reason: CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
Code information: Lot #: 174096, Exp 05/31/19
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations