February 2022 FDA Recall Clotrimazole And Betamethasone Dipropionate by Taro Pharmaceuticals U.s.a., Inc.
D-0727-2022 - Failed Content Uniformity Specifications

This Class III drug recall was voluntarily initiated by Taro Pharmaceuticals U.s.a., Inc. on February 25, 2022 for the product Clotrimazole And Betamethasone Dipropionate. The FDA reported the reason for recall as failed content uniformity specifications. The product was distributed in Product was distributed to one retail consignee in NY. and the recall is currently terminated.

Recall Number: D-0727-2022

Reason for Recall
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Initiated
02-25-2022
Reported
04-06-2022
Quantity
768 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89678
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.
Product was distributed to one retail consignee in NY.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-09-2024
Product Description About Product Description
Full technical description of the product.
Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4048-1

Batch or Lot Expiration Information

Lot# : AC33883, Exp. Date June 2023

Affected Packages Involved in this Recall

51672-4048-1 Clotrimazole And Betamethasone Dipropionate
51672-4048-6 Clotrimazole And Betamethasone Dipropionate