Recall Enforment Report D-0116-2017

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Taro Pharmaceuticals, Inc., originally initiated on 09-13-2016 for the 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 The product was recalled due to failed stability specifications: the subject lots exhibited oos results for homogeneity test (moderate separation).. The product was distributed in Us & Puerto Rico and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0116-201709-13-201611-09-2016Class II15,576 unitsDesoximetasone 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 51672-1270-7Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).Terminated
D-0117-201709-13-201611-09-2016Class II6,756 unitsDesoximetasone Cream USP, 0.05% 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 51672-1271-7Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
51672-1261Desoximetasone DesoximetasoneGelTopicalSun Pharmaceutical Industries, Inc.Human Prescription Drug
51672-1270Desoximetasone DesoximetasoneCreamTopicalSun Pharmaceutical Industries, Inc.Human Prescription Drug
51672-1271Desoximetasone DesoximetasoneCreamTopicalSun Pharmaceutical Industries, Inc.Human Prescription Drug