drugs Class III Updated 2013-12-18

Sandoz Inc recalls Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle,

Recalled 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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: a) CU6131, b) CW1161
View official government recall

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