D-1370-2015 Class III Terminated

Recalled by Taro Pharmaceuticals, Inc. — Brampton, N/A

Recall Details

Product Type
Drugs
Report Date
September 2, 2015
Initiation Date
August 5, 2015
Termination Date
April 3, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16,320 Bottles

Product Description

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 Pattern

U.S. Nationwide

Code Information

Lot #: C4177-14965, Expiry: February 2016; Lot #: C4178-14965, Expiry: February 2016.