FDA recall D-1370-2015

Product

Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada, L6T 1C1, Dist by: TaroPharma, Hawthorne, NY 10532. NDC: 51672-5281-7.

Reason for recall

Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.

Distribution

U.S. Nationwide

Key facts

Status

Terminated

Initiation date

2015-08-05

Report date

2015-09-02

Termination date

2017-04-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brampton, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1370-2015