Upsher Smith Laboratories, Inc. recalls Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove,…
- Recall date
- September 19, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0281-2019
- FDA classification
- Class II
- Brand / firm
- Upsher Smith Laboratories, Inc.
- Sold / distributed
- Nationwide USA, Puerto Rico and Guam
Why it was recalled
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11
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