Recall: D-0167-2024

Class II - Potentially Harmful

Class IIClassification

2022-01-26Initiated

TerminatedStatus

CARDINAL HEALTHCAREFirm

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.

Distribution

Nationwide USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.