Drug & medication recalls Moderate risk

Taro Pharmaceuticals, Inc. recalls Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Di…

Recall date
September 13, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0116-2017
FDA classification
Class II
Brand / firm
Taro Pharmaceuticals, Inc.
Sold / distributed
US & Puerto Rico

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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