Topicort Spray
FDA Recall NDC 51672-5281
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 Topicort (NDC 51672-5281). A significant event, classified as Class III, was initiated on Aug 05, 2015 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points."
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
August 2015 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.
Aug 05, 2015
Sep 02, 2015
16,320 Bottles
Recall Profile & Regulatory Data
Event ID
71845
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Taro Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Termination Date
Apr 03, 2017
Product Description
Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada, L6T 1C1, Dist by: TaroPharma, Hawthorne, NY 10532. NDC: 51672-5281-7.
Batch or Lot Expiration Information
Lot# : C4177-14965, Expiry: February 2016
Lot# : C4178-14965, Expiry: February 2016.
Affected Packages Involved in this Recall
51672-5281-0Product
51672-5281-3Product
51672-5281-4Product
51672-5281-7Product
51672-5281-6Product
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.
