Drug product
Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by : Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 UPC 351672125837 NDC 51672-1258-3
D-0249-2018
Product summary
- Event
- Event 79029
- Status
- Terminated
- Classification
- Class III
- Quantity
- 27,792 tubes
- Official record key
drug-enforcement:D-0249-2018
Official wording
Reason: Failed Content Uniformity Specifications
Code information: Lot 311235, exp Sept 2018
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Content Uniformity Specifications