Nystatin And Triamcinolone Acetonide Ointment
FDA Recall NDC 51672-1272
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 Nystatin And Triamcinolone Acetonide (NDC 51672-1272). A significant event, classified as Class II, was initiated on Mar 28, 2017 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability"
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
March 2017 Class II Recall: Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Recall Number
Class II Terminated
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Mar 28, 2017
Apr 26, 2017
278,304 tubes
Recall Profile & Regulatory Data
Event ID
76954
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Taro Pharmaceuticals U.S.A., Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jun 17, 2019
Product Description
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a) 15 grams (NDC 51672-1263-1), b) 30 grams (NDC 51672-1263-2) and c) 60 grams (NDC 51672-1263-3) tubes, Rx only, TARO label; Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1 -- Dist. by: Taro Pharmaceuticals U.S.A. Inc., Hawthorne, NY 10532
Batch or Lot Expiration Information
Lot# a) 15 g: Lot B505118501, exp. date January 2018; b) 30 g: Lot B504918500, exp. date January 2018; c) 60 g: Lots: I416616979, exp. date August 2017, I416716979, exp. date August 2017 and D504519119, exp. date March 2018
Affected Packages Involved in this Recall
51672-1272-1Product
51672-1272-2Product
51672-1272-3Product
51672-1263-1Product
51672-1263-2Product
51672-1263-3Product
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.
