FDAFDA · Food and drugs·Recall number D-341-2014
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
Published December 18, 2013 · Recall initiated: November 6, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BUMETANIDE
- Manufacturer
- Sandoz Inc
- Distributor
- Nationwide
- UPC
- 0301850128013
- Lot
- Lot #: a) CU6131, b) CW1161
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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