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
Reported: December 18, 2013 Initiated: November 6, 2013 #D-341-2014
Product Description
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.
Details
- Recalling Firm
- Sandoz Inc
- Units Affected
- 11,496 bottles (100 count) and 62 bottles (500 count)
- Distribution
- Nationwide
- Location
- Wilson, NC
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Sandoz Inc. Units affected: 11,496 bottles (100 count) and 62 bottles (500 count).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 18, 2013. Severity: Low. Recall number: D-341-2014.
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