Recall Enforment Report D-1497-2022

Drug Recall Enforcement Report Class II voluntary initiated by Padagis US LLC, originally initiated on 08-17-2022 for the product 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. The product was recalled due to cgmp deviations: product complaints reporting the product to have a gritty texture and lack of effectiveness.. The product was distributed nationwide and the recall is currently ongoing.

Field Name Field Value
Event ID 90790 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-1497-2022 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern Nationwide in the USA What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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.
Reason For Recall CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness. What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 57,816 tubes Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 09-07-2022
Recall Initiation Date 08-17-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm Padagis US LLC
Code Info Lot 2CT0486 , Exp 02/29/2024 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages 45802-063-35; 45802-063-36; 45802-063-05; 45802-064-35; 45802-064-36; 45802-064-05; 45802-065-35
Status Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
45802-063Triamcinolone Acetonide Triamcinolone AcetonideCreamTopicalPadagis Israel Pharmaceuticals LtdHuman Prescription Drug
45802-064Triamcinolone Acetonide Triamcinolone AcetonideCreamTopicalPadagis Israel Pharmaceuticals LtdHuman Prescription Drug
45802-065Triamcinolone Acetonide Triamcinolone AcetonideCreamTopicalPadagis Israel Pharmaceuticals LtdHuman Prescription Drug