FDA recall D-0171-2024

Product

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

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-0171-2024