Clotrimazole And Betamethasone Dipropionate Cream
FDA Recall NDC 51672-4048
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Clotrimazole And Betamethasone Dipropionate (NDC 51672-4048). A significant event, classified as Class III, was initiated on Feb 25, 2022 by Taro Pharmaceuticals U.s.a., Inc.. The reported reason for this action was: "Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Feb 25, 2022
Apr 06, 2022
768 tubes
Recall Profile & Regulatory Data
Event ID
89678
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Taro Pharmaceuticals U.S.A., Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed to one retail consignee in NY.
Termination Date
Sep 09, 2024
Product Description
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
51672-4048-1Product
51672-4048-6Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
