Recall Enforment Report D-0006-2023

Recall Details

Drug Recall Enforcement Report Class III voluntary initiated by Woodbine Products Co Inc, originally initiated on 08-30-2022 for the product Antibacterial Foaming Wash with Hydria Moisturizing Formula, Cucumber-Melon Scent, 1250 mL (42 fl oz.), Manufactured for: Triple S, 800-323-2251, Made in USA, NDC 11429-1010-8 The product was recalled due to labeling: not elsewhere classified - incorrect label-incorrect scent listed on label.. The product was distributed in Nc and the recall is currently terminated.

Field Name Field Value
Event ID 90846 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0006-2023 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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 NC 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 Antibacterial Foaming Wash with Hydria Moisturizing Formula, Cucumber-Melon Scent, 1250 mL (42 fl oz.), Manufactured for: Triple S, 800-323-2251, Made in USA, NDC 11429-1010-8
Reason For Recall Labeling: Not Elsewhere Classified - Incorrect label-incorrect scent listed on label. What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 595 cases (4 bottles per case) 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 10-12-2022
Recall Initiation Date 08-30-2022 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Termination Date 09-28-2023 What is the Date Terminated?
The date that FDA terminated the recall.
Initial Firm Notification Telephone 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 Woodbine Products Co Inc
Code Info Lot #: VDAF017, Exp 4/24; VDAF018, Exp 5/24 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 11429-1010-1; 11429-1010-7; 11429-1010-3; 11429-1010-8
Status Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
11429-1010Foamfresh Dye Free Antibacterial Hand Wash ChloroxylenolSolutionTopicalWoodbine Products CompanyHuman Otc Drug