FDA recall D-0146-2018

Product

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-09-20

Report date

2017-11-01

Termination date

2020-09-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hawthorne, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0146-2018