Drug 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
D-341-2014
Product summary
- Firm
- Sandoz Inc
- Event
- Event 66791
- Status
- Terminated
- Classification
- Class III
- Quantity
- 11,496 bottles (100 count) and 62 bottles (500 count)
- Official record key
drug-enforcement:D-341-2014
Official wording
Reason: 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.
Code information: Lot #: a) CU6131, b) CW1161
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out of Specification