November 02, 2018
Upsher Smith Laboratories is recalling 100-count bottles of bumetanide tablets, USP, because the medication is out of specification for a degradation ingredient, according to the October 31, 2018, US Food and Drug Administration (FDA) Enforcement Report.
The recall includes the following formulations, which were distributed in the United States, Puerto Rico, and Guam:
- 1-mg tablets (NDC 0832-0541-11) from lots 375716 (Exp. 4/30/20), 372957, 372958, and 372959 (Exp 3/31/20), and 374541, 375717, and 376688 (Exp. 5/31/20); and
- 2-mg tablets (NDC 0832-0542-11) from lots 372461, 372952, 372954, 372955, 373624, and 374539 (Exp. 3/31/20) and 375719, 375721, and 376684 (Exp. 5/31/20).
Upsher Smith Laboratories voluntarily initiated the recall September 19, 2018. As of press time, the FDA had not yet designated a recall classification.
Bumetanide is a prescription diuretic used to treat fluid retention and high blood pressure.
For more Pharmacy Learning Network articles, visit the homepage
To learn about Pharmacy Learning Network Live meetings, click here