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

Recalled December 18, 2013 · FDA recall D-341-2014 · Sandoz

Hazard

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. · FDA Class III

Units

11,496 bottles (100 count) and 62 bottles (500 count)

Sold at

Nationwide

Description

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.

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

Manufacturer(s)

Sandoz Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →