Clobetasol Propionate Ointment
FDA Recall NDC 51672-1259
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Clobetasol Propionate (NDC 51672-1259). A significant event, classified as Class I, was initiated on Dec 15, 2021 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria"
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
December 2021 Class I Recall: Microbial Contamination of Non-Sterile Products
Recall Number
Class I Terminated
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Dec 15, 2021
Jan 19, 2022
96 tubes
Recall Profile & Regulatory Data
Event ID
89241
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Taro Pharmaceuticals U.S.A., Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Two distributors in UT and LA who could have further distributed to the retail level nationwide in the USA.
Termination Date
Dec 04, 2023
Product Description
Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC 51672-1259-3
Batch or Lot Expiration Information
Lot# AC13786, exp. date DEC 2022
Affected Packages Involved in this Recall
51672-1294-1Product
51672-1294-2Product
51672-1294-3Product
51672-1258-1Product
51672-1258-2Product
51672-1258-6Product
51672-1258-3Product
51672-1259-1Product
51672-1259-2Product
51672-1259-6Product
51672-1259-3Product
Class III Terminated
Failed Content Uniformity Specifications
Dec 21, 2017
Feb 07, 2018
27,792 tubes
Recall Profile & Regulatory Data
Event ID
79029
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Taro Pharmaceuticals U.S.A., Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 21, 2020
Product Description
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
Affected Packages Involved in this Recall
51672-1294-1Product
51672-1294-2Product
51672-1294-3Product
51672-1258-1Product
51672-1258-2Product
51672-1258-6Product
51672-1258-3Product
51672-1259-1Product
51672-1259-2Product
51672-1259-6Product
51672-1259-3Product
3516721258Product
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.
