Reported Oct 31, 2018 · Terminated
Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove,…
Upsher Smith Laboratories, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Upsher Smith Laboratories, Inc. · 6701 Evenstad Dr N · Maple Grove, MN · 55369-6026
Is this the product you have?
- Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only
- Manufactured byUpser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11
- Lot codes and dates
Lot#: 375716Exp 4/30/2020372957372958372959Exp 3/31/2020374541375717376688Exp 5/31/2020
- Amount recalled
- 44,764 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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