Triamcinolone Acetonide Cream
FDA Recall NDC 72189-330
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 72189-330). A significant event, classified as Class II, was initiated on Sep 12, 2022 by Direct Rx. 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 COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Sep 12, 2022
Sep 21, 2022
20 tubes
Recall Profile & Regulatory Data
Event ID
90869
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Direct Rx
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Physicians and Medical Facilities in GA and ID
Product Description
Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80.
Batch or Lot Expiration Information
Lot# Lot: 12JY2216, Exp. 2/29/24
Affected Packages Involved in this Recall
72189-330-80Product
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.
