Fluocinonide Ointment
FDA Recall NDC 51672-1264
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 Fluocinonide (NDC 51672-1264). A significant event, classified as Class III, was initiated on Sep 20, 2017 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Cross contamination with other products: traces of Dapsone were found in the finished product."
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
Cross contamination with other products: traces of Dapsone were found in the finished product.
Sep 20, 2017
Nov 01, 2017
16,944 tubes
Recall Profile & Regulatory Data
Event ID
78157
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 10, 2020
Product Description
Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton Ontario Canada L6T1C1, Dist. by: Taro Pharmaceuticals U.S.A . Inc. Hawthorne NY 10532, NDC 51672-1279-1
Batch or Lot Expiration Information
Lot# : A771026850, Exp 6/18
Affected Packages Involved in this Recall
51672-1253-1Product
51672-1253-2Product
51672-1253-3Product
51672-1253-4Product
51672-1254-1Product
51672-1254-2Product
51672-1254-3Product
51672-1279-1Product
51672-1279-2Product
51672-1279-3Product
51672-1264-1Product
51672-1264-2Product
51672-1264-3Product
Class III Terminated
Cross contamination with other products: Certain lots of Fluocinonide Cream were found to be contaminated with a small quantity of hydrocortisone-17-valerate.
Mar 17, 2017
May 24, 2017
7,776 tubes
Recall Profile & Regulatory Data
Event ID
76837
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Taro Pharmaceuticals U.S.A., Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Termination Date
Aug 24, 2021
Product Description
Fluocinonide Cream UPS, 0.05% (Emulsified Base), packaged in 60 g tube, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, Dist. by Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1254-3
Batch or Lot Expiration Information
Lot# : D301311473, D301411473, Exp 3/2017
Affected Packages Involved in this Recall
51672-1253-1Product
51672-1253-2Product
51672-1253-3Product
51672-1253-4Product
51672-1254-1Product
51672-1254-2Product
51672-1254-3Product
51672-1279-1Product
51672-1279-2Product
51672-1279-3Product
51672-1264-1Product
51672-1264-2Product
51672-1264-3Product
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.
