FDA recall D-0167-2024

CARDINAL HEALTHCARE · Class II · drug

Product

Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 65162-897-03

Reason for recall

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Distribution

Nationwide USA

Key facts

Status
Terminated
Initiation date
2022-01-26
Report date
2024-01-03
Termination date
2024-09-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dublin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0167-2024