Taro Pharmaceuticals U.S.A., Inc. recalls Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada L6T1C1, Dis…

Recall date

September 20, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0146-2018

FDA classification

Class III

Brand / firm

Taro Pharmaceuticals U.S.A., Inc.

Sold / distributed

Nationwide

Why it was recalled

Cross contamination with other products: traces of Dapsone were found in the finished product.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada L6T1C1, Dist. by: Taro Pharmaceuticals U.S.A . Inc. Hawthorne NY 10532, NDC 51672-1279-1