FDA-Drug2024-01-03Class II

Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213 India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807

CARDINAL HEALTHCARE
Hazard

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

Sold states
Nationwide USA
Affected count
1 unit
Manufactured in
7200 Cardinal Pl W, Dublin, OH, United States
Products
Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213 India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0171-2024

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