BEUDAMED
    FDA Enforcement Class II Ongoing

    Eye and Ear Dropper, Product Code 67082

    Recall: Z-1702-2023 · Reported June 21, 2023

    Enforcement

    Recall Number
    Z-1702-2023
    Event ID
    92247
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Apothecary Products, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 21, 2023
    Initiation Date
    March 30, 2023
    Classification Date
    June 9, 2023
    Address
    11750 12th Ave S, N/A, Burnsville, MN, 55337-1297, United States

    Description

    Eye and Ear Dropper, Product Code 67082

    Reason

    Potential for glass dropper to have glass particulate on the outside surface of the dropper bulb.

    Code Info

    Lot Number: 030923; UPC Number: 025715670829

    Distribution

    Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, HI, IL, IN, MO, NC, NJ, NY, OK, OR, PA, TN, TX, UT, WA and the country of Canada.

    Quantity

    2,346 units