October 2013 FDA Recall Ciclopirox by Taro Pharmaceuticals U.s.a., Inc.
D-347-2014 - Subpotent. drug
This Class III drug recall was voluntarily initiated by Taro Pharmaceuticals U.s.a., Inc. on October 16, 2013 for the product Ciclopirox. The FDA reported the reason for recall as subpotent. drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-347-2014
Subpotent. drug
10-16-2013
12-18-2013
850 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 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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
05-18-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only. Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1. Dist. by: TARO Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-1351-8.
Batch or Lot Expiration Information
Lot# : H3135, Exp. January 2015
