FDA-Drug2024-01-03Class II

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

CARDINAL HEALTHCARE
Hazard

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

Sold states
Nationwide USA
Affected count
2 units
Manufactured in
7200 Cardinal Pl W, Dublin, OH, United States
Products
Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 65162-897-03

Official notice

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

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