BEUDAMED
    FDA Enforcement Class II Ongoing

    ARC TEETH WHITENING PEN 0.06 FL OZ, SKU 997950

    Recall: Z-0268-2024 · Reported November 15, 2023

    Enforcement

    Recall Number
    Z-0268-2024
    Event ID
    93216
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Family Dollar Stores, Llc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 15, 2023
    Initiation Date
    October 4, 2023
    Classification Date
    November 7, 2023
    Address
    500 Volvo Pkwy, Chesapeake, VA, 23320-1604, United States

    Description

    ARC TEETH WHITENING PEN 0.06 FL OZ, SKU 997950

    Reason

    Products were stored outside of labeled temperature requirements.

    Code Info

    All units sold at stores between June 1, 2023 and October 4, 2023.

    Distribution

    Distributed to Family Dollar stores in the following states: GA, AL, MS, FL, LA, AR, AZ, KS, TX, OK, CO, NM, NE, UT, NV, WY, ID, SD, ND, CA, MT, OR, WA.

    Quantity

    329,044 total units