July 2020 FDA Recall Drug by Taro Pharmaceuticals U.s.a., Inc.
D-1496-2020 - Failed Content Uniformity

This Class III drug recall was voluntarily initiated by Taro Pharmaceuticals U.s.a., Inc. on July 20, 2020 for the product Drug. The FDA reported the reason for recall as failed content uniformity. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1496-2020

Reason for Recall
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Initiated
07-20-2020
Reported
08-19-2020
Quantity
7632 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86101
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-20-2023
Product Description About Product Description
Full technical description of the product.
Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx Only, For External Use Only, Not for Ophthalmic Use, Mfd by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Marketed by: Golden State Medical Supply, Inc. Camarillo, CA 93012.

Batch or Lot Expiration Information

Lot# a) AB28353, Exp 12/31/2021; b) AB40178, Exp 12/31/2021