FDA recall D-0790-2017

Taro Pharmaceuticals U.S.A., Inc. · Class III · drug

Product

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.

Distribution

U.S. Nationwide

Key facts

Status: Terminated
Initiation date: 2017-03-17
Report date: 2017-05-24
Termination date: 2021-08-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Hawthorne, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0790-2017