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

Recall Number: D-0171-2024

Firm: CARDINAL HEALTHCARE

Classification: Class II

Status: Terminated

Report Date: 20240103

Initiation Date: 20220126

Termination Date: 20240929

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

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