Drug recall
Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC…
FDA recall event 81174 · Class II · Upsher Smith Laboratories, Inc.
Key facts
| Event ID | 81174 |
|---|---|
| Recall numbers | D-0280-2019, D-0281-2019 |
| Recalling firm | Upsher Smith Laboratories, Inc. |
| Product type | Drugs |
| 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, Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product. |
| Initiation date | Sep 19, 2018 |
| Report date | Oct 31, 2018 |
| Termination date | Sep 30, 2020 |
| City | Maple Grove |
| State | MN |
| Country | United States |
| FEI number | 3004106442 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: