FDA (Drugs) recall action 81174
The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Upsher Smith is recalling Bumetanide tablets because the product failed impurity specifications for an unspecified degradation product.
Upsher Smith Laboratories is recalling 29,080 bottles of Bumetanide 2 mg tablets because the product failed impurity specifications for an unspecified degradation product.