August 2015 FDA Recall Topicort by Taro Pharmaceuticals, Inc.
D-1370-2015 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Taro Pharmaceuticals, Inc. on August 5, 2015 for the product Topicort. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1370-2015
Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.
08-05-2015
09-02-2015
16,320 Bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Taro Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide
04-03-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# : C4177-14965, Expiry: February 2016
Lot# : C4178-14965, Expiry: February 2016.
