Drug product
Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11
D-0281-2019
Product summary
- Event
- Event 81174
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29,080 bottles
- Official record key
drug-enforcement:D-0281-2019
Official wording
Reason: Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Code information: Lot#: 372461, 372952, 372954, 372955, 373624, 374539, Exp 3/31/2020; 375719, 375721, 376684, Exp 5/31/2020
Distribution pattern: Nationwide USA, Puerto Rico and Guam
Derived failure modes
-
Potency or specification failure
Out of Specification