December 2017 FDA Recall Clobetasol Propionate by Taro Pharmaceuticals U.s.a., Inc.
D-0249-2018 - Failed Content Uniformity Specifications
This Class III drug recall was voluntarily initiated by Taro Pharmaceuticals U.s.a., Inc. on December 21, 2017 for the product Clobetasol Propionate. The FDA reported the reason for recall as failed content uniformity specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0249-2018
Failed Content Uniformity Specifications
12-21-2017
02-07-2018
27,792 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
09-21-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by : Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 UPC 351672125837 NDC 51672-1258-3
Batch or Lot Expiration Information
Lot# Lot 311235, exp Sept 2018
