Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11

Recall Number: D-0281-2019

Firm: Upsher Smith Laboratories, Inc.

Classification: Class II

Status: Terminated

Report Date: 20181031

Initiation Date: 20180919

Termination Date: 20200930

Reason for Recall

Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.

Product Description

Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11