Drug recall D-0116-2017
Product
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).
Lots and codes
Lot #: B5093-18608, B5094-18608, Exp. Jan 2017; Lot #: C5141-18954, C5142-18954, E5109-19625, Exp . Feb 2017
Recall details
- Recalling firm
- Taro Pharmaceuticals, Inc., Brampton
- Quantity
- 15,576 units
- Distribution
- US & Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 13, 2016
- Terminated
- June 15, 2018
Related products
- Desoximetasone – drug information
- NDC 51672-1271 Desoximetasone · Desoximetasone .5 mg/g · Sun Pharmaceutical Industries, Inc.
- NDC 51672-1270 Desoximetasone · Desoximetasone 2.5 mg/g · Sun Pharmaceutical Industries, Inc.
- NDC 51672-1261 Desoximetasone · Desoximetasone .5 mg/g · Sun Pharmaceutical Industries, Inc.