Multi event Drug Recall Enforcement Report Class II voluntary initiated by Upsher Smith Laboratories, Inc., originally initiated on 09-19-2018 for the product Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11 The product was recalled due to failed impurities/ degradation specifications: product is out of specification for an unspecified degradation product.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
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 | Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product. | 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 | Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product. | Terminated |
Recalled Products
