PlainRecalls
FDA Drug Low Class III Terminated

Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1254-3

Reported: May 24, 2017 Initiated: March 17, 2017 #D-0790-2017

Product Description

Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1254-3

Reason for Recall

Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.

Details

Units Affected
7,776 tubes
Distribution
U.S. Nationwide
Location
Hawthorne, NY

Frequently Asked Questions

What product was recalled?
Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1254-3. Recalled by Taro Pharmaceuticals U.S.A., Inc.. Units affected: 7,776 tubes.
Why was this product recalled?
Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 24, 2017. Severity: Low. Recall number: D-0790-2017.