Recall: D-0116-2017

Class II - Potentially Harmful

Class IIClassification

2016-09-13Initiated

TerminatedStatus

Taro Pharmaceuticals, Inc.Firm

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

Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).

Distribution

US & Puerto Rico

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.