FDA-Drug2018-10-31Class II
Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11
Upsher Smith Laboratories, Inc.
Hazard
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Sold states
Nationwide USA, Puerto Rico and Guam
Affected count
44,764 bottles
Manufactured in
6701 Evenstad Dr N, N/A, Maple Grove, MN, United States
Products
Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0280-2019Don't want to check this manually?
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