FDA recall D-0249-2018

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

Product

Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by : Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 UPC 351672125837 NDC 51672-1258-3

Reason for recall

Failed Content Uniformity Specifications

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2017-12-21
Report date
2018-02-07
Termination date
2020-09-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hawthorne, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0249-2018