D-0146-2018 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 1, 2017
- Initiation Date
- September 20, 2017
- Termination Date
- September 10, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16,944 tubes
Product Description
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
Reason for Recall
Cross contamination with other products: traces of Dapsone were found in the finished product.
Distribution Pattern
Nationwide
Code Information
Lot #: A771026850, Exp 6/18