FDA recall D-341-2014

Product

Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ 08540, NDC a) 0185-0128-01, b) 0185-0128-05

Reason for recall

Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-11-06

Report date

2013-12-18

Termination date

2014-05-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wilson, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-341-2014