Upsher Smith Laboratories, Inc. recalls Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove,
Recalled October 31, 2018 · FDA recall D-0281-2019 · Upsher Smith Laboratories
Hazard
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product. · FDA Class II
Units
29,080 bottles
Sold at
Nationwide USA, Puerto Rico and Guam
Description
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Product
Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11
Manufacturer(s)
Upsher Smith Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →