Class III
Terminated
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
- Company
- Sandoz Inc
- Recall Initiated
- November 6, 2013
- Posted
- December 18, 2013
- Recall Number
- D-341-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 11,496 bottles (100 count) and 62 bottles (500 count)
- Firm Location
- Wilson, NC, United States
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
Lot / Code Info
Lot #: a) CU6131, b) CW1161
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