D-0116-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 9, 2016
- Initiation Date
- September 13, 2016
- Termination Date
- June 15, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,576 units
Product Description
Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1270-7
Reason for Recall
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Distribution Pattern
US & Puerto Rico
Code Information
Lot #: B5093-18608, B5094-18608, Exp. Jan 2017; Lot #: C5141-18954, C5142-18954, E5109-19625, Exp . Feb 2017