FDA recall D-0281-2019

Upsher Smith Laboratories, Inc. · Class II · 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

Reason for recall

Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.

Distribution

Nationwide USA, Puerto Rico and Guam

Key facts

Status
Terminated
Initiation date
2018-09-19
Report date
2018-10-31
Termination date
2020-09-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Maple Grove, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0281-2019