FDA Recall Bumetanide
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Bumetanide with NDC 0832-0542 was initiated on 09-19-2018 as a Class II recall due to failed impurities/ degradation specifications: product is out of specification for an unspecified degradation product. The latest recall number for this product is D-0280-2019 and the recall is currently terminated as of 09-30-2020 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-0280-2019 | 09-19-2018 | 10-31-2018 | Class II | 44,764 bottles | Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11 | Terminated |
| D-0281-2019 | 09-19-2018 | 10-31-2018 | Class II | 29,080 bottles | Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11 | Terminated |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.