Desoximetasone Cream
FDA Recall NDC 51672-1271
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 Desoximetasone (NDC 51672-1271). A significant event, classified as Class II, was initiated on Sep 13, 2016 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation)."
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 II Terminated
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Sep 13, 2016
Nov 09, 2016
15,576 units
Recall Profile & Regulatory Data
Event ID
75349
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Taro Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US & Puerto Rico
Termination Date
Jun 15, 2018
Product Description
Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1270-7
Batch or Lot Expiration Information
Lot# : B5093-18608, B5094-18608, Exp. Jan 2017
Lot# : C5141-18954, C5142-18954, E5109-19625, Exp . Feb 2017
Affected Packages Involved in this Recall
51672-1271-1Product
51672-1271-2Product
51672-1271-3Product
51672-1271-7Product
51672-1270-1Product
51672-1270-2Product
51672-1270-3Product
51672-1270-7Product
51672-1261-1Product
51672-1261-2Product
51672-1261-3Product
Class II Terminated
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Sep 13, 2016
Nov 09, 2016
6,756 units
Recall Profile & Regulatory Data
Event ID
75349
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Taro Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US & Puerto Rico
Termination Date
Jun 15, 2018
Product Description
Desoximetasone Cream USP, 0.05% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1271-7
Batch or Lot Expiration Information
Lot# : E0598-19624, E5099-19624, Exp. Jan 2017
Affected Packages Involved in this Recall
51672-1271-1Product
51672-1271-2Product
51672-1271-3Product
51672-1271-7Product
51672-1270-1Product
51672-1270-2Product
51672-1270-3Product
51672-1270-7Product
51672-1261-1Product
51672-1261-2Product
51672-1261-3Product
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.
