Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11

FDA recall notice · announced October 31, 2018 · Upsher Smith Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide USA, Puerto Rico and Guam
Lot/code information: Lot#: 372461, 372952, 372954, 372955, 373624, 374539, Exp 3/31/2020; 375719, 375721, 376684, Exp 5/31/2020
Quantity: 29,080 bottles
Status: Terminated
Products in this recall event:
- Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11 (D-0280-2019)
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.