September 2017 FDA Recall Fluocinonide by Taro Pharmaceuticals U.s.a., Inc.
D-0146-2018 - Cross contamination with other products
This Class III drug recall was voluntarily initiated by Taro Pharmaceuticals U.s.a., Inc. on September 20, 2017 for the product Fluocinonide. The FDA reported the reason for recall as cross contamination with other products. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0146-2018
Cross contamination with other products: traces of Dapsone were found in the finished product.
09-20-2017
11-01-2017
16,944 tubes
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 U.S.A., 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.
Nationwide
09-10-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : A771026850, Exp 6/18
