Reported Nov 1, 2017 · Terminated

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

Taro Pharmaceuticals U.S.A., Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Taro Pharmaceuticals U.S.A., Inc. · 3 Skyline Dr · Hawthorne, NY · 10532-2174

Is this the product you have?

  • Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd
  • byTaro Pharmaceuticals Inc. Brampton Ontario Canada L6T1C1, Dist
  • byTaro Pharmaceuticals U.S.A . Inc. Hawthorne NY 10532, NDC 51672-1279-1
Lot codes and dates
    • Lot #: A771026850
    • Exp 6/18
Amount recalled
16,944 tubes

Where it was sold

  • Nationwide

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 10, 2020 · Data as of Sep 19, 6:28 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.