PlainRecalls
FDA Drug Moderate Class II Terminated

Desoximetasone 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 51672-1271-7

Reported: November 9, 2016 Initiated: September 13, 2016 #D-0117-2017

Product Description

Desoximetasone 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 51672-1271-7

Reason for Recall

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

Details

Units Affected
6,756 units
Distribution
US & Puerto Rico
Location
Brampton

Frequently Asked Questions

What product was recalled?
Desoximetasone 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 51672-1271-7. Recalled by Taro Pharmaceuticals, Inc.. Units affected: 6,756 units.
Why was this product recalled?
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Which agency issued this recall?
This recall was issued by the FDA Drug on November 9, 2016. Severity: Moderate. Recall number: D-0117-2017.