Drug product
Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada L6T1C1, Dist. by: Taro Pharmaceuticals U.S.A . Inc. Hawthorne NY 10532, NDC 51672-1279-1
D-0146-2018
Product summary
- Event
- Event 78157
- Status
- Terminated
- Classification
- Class III
- Quantity
- 16,944 tubes
- Official record key
drug-enforcement:D-0146-2018
Official wording
Reason: Cross contamination with other products: traces of Dapsone were found in the finished product.
Code information: Lot #: A771026850, Exp 6/18
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Cross contamination with other products: traces of Dapsone were found in the finished product.