Drug product
Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA, NDC 62332-097-30.
D-1341-2020
Product summary
- Event
- Event 85835
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,153 bottles
- Official record key
drug-enforcement:D-1341-2020
Official wording
Reason: Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
Code information: Lot: 1905003298 Exp. 01/31/2021
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Labeling or packaging
Labeling: Label mix up