Drug recall D-341-2014

Class III Terminated reported Dec 18, 2013

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.

Lots and codes

Lot #: a) CU6131, b) CW1161

Recall details

Recalling firm
Sandoz Inc, Wilson, NC
Quantity
11,496 bottles (100 count) and 62 bottles (500 count)
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
November 6, 2013
Terminated
May 29, 2014

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