Drug recall D-0281-2019
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
Reason for recall
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Lots and codes
Lot#: 372461, 372952, 372954, 372955, 373624, 374539, Exp 3/31/2020; 375719, 375721, 376684, Exp 5/31/2020
Recall details
- Recalling firm
- Upsher Smith Laboratories, Inc., Maple Grove, MN
- Quantity
- 29,080 bottles
- Distribution
- Nationwide USA, Puerto Rico and Guam
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 19, 2018
- Terminated
- September 30, 2020
Related products
- Bumetanide – drug information
- NDC 0832-0540 Bumetanide · Bumetanide .5 mg/1 · Upsher-Smith Laboratories, LLC
- NDC 0832-0541 Bumetanide · Bumetanide 1 mg/1 · Upsher-Smith Laboratories, LLC
- NDC 0832-0542 Bumetanide · Bumetanide 2 mg/1 · Upsher-Smith Laboratories, LLC