Recalls / Class III
Class IIID-341-2014
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
- Brand name
- Bumetanide
- Generic name
- Bumetanide
- Active ingredient
- Bumetanide
- Route
- Oral
- NDCs
- 0185-0128, 0185-0129, 0185-0130
- FDA application
- ANDA074700
- Affected lot / code info
- Lot #: a) CU6131, b) CW1161
Why it was 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.
Recalling firm
- Firm
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4700 Sandoz Dr, Wilson, North Carolina 27893-8143
Distribution
- Quantity
- 11,496 bottles (100 count) and 62 bottles (500 count)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-11-06
- FDA classified
- 2013-12-06
- Posted by FDA
- 2013-12-18
- Terminated
- 2014-05-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-341-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.