FDA Recall Foamfresh Dye Free Antibacterial Hand Wash

The most recent Recall Enforcement Report that covers this product was initiated on August 30th, 2022 and classified as a Class III recall due to labeling: not elsewhere classified - incorrect label-incorrect scent listed on label. This recall is currently terminated, and the associated recall number is recall number is D-0006-2023. It pertains to Foamfresh Dye Free Antibacterial Hand Wash identified by 11429-1010 as of 09-28-2023 .

Recall Number D-0006-2023

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/dt>

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.

View Recall Report

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.