Status
Terminated
Drug Enforcement D-341-2014
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.
Classification
Class III
Report Date
December 18, 2013
Termination Date
May 29, 2014
Product Information
- 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
- Product quantity
- 11,496 bottles (100 count) and 62 bottles (500 count)
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Sandoz Inc
- Address
-
4700 Sandoz Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-341-2014
- Event ID
- 66791
- Recall initiation date
- November 6, 2013
- Center classification date
- December 6, 2013
- Code info
- Lot #: a) CU6131, b) CW1161
- More code info
- —