Class II Recall

CARDINAL HEALTHCARE

Product
Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 65162-897-03
Reason
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Classification
Class II
Status
Terminated
Lot
Batch AR202318
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.