Triamcinolone Acetonide Cream
FDA Recall NDC 45802-063
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 Triamcinolone Acetonide (NDC 45802-063). A significant event, classified as Class II, was initiated on Aug 17, 2022 by Padagis Israel Pharmaceuticals Ltd. The reported reason for this action was: "CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness."
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
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Aug 17, 2022
Sep 07, 2022
57,816 tubes
Recall Profile & Regulatory Data
Event ID
90790
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Padagis US LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Sep 28, 2023
Product Description
Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, MI 49010, NDC 45802-064-36.
Batch or Lot Expiration Information
Lot# Lot 2CT0486 , Exp 02/29/2024
Affected Packages Involved in this Recall
45802-063-35Product
45802-063-36Product
45802-063-05Product
45802-064-35Product
45802-064-36Product
45802-064-05Product
45802-065-35Product
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.
