Nystatin And Triamcinolone Acetonide Cream
FDA Recall NDC 68180-545
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 68180-545). A significant event, classified as Class III, was initiated on Jul 17, 2019 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation."
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
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Jul 17, 2019
Jul 31, 2019
33,939 tubes
Recall Profile & Regulatory Data
Event ID
83350
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Sep 14, 2020
Product Description
Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-545-01
Batch or Lot Expiration Information
Lot# : K800245, Exp. Dec 2019; K900036 Exp. Sep 20; K900153, Exp. 09/2020
Affected Packages Involved in this Recall
68180-545-02Product
68180-545-03Product
68180-545-01Product
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.
