BEUDAMED
    FDA Recall Open, Classified

    Eye and Ear Dropper, Product Code 67082

    Recall: Z-1702-2023 · Initiated March 30, 2023

    Recall

    Recall Number
    Z-1702-2023
    Event Number
    92247
    Firm
    Apothecary Products, LLC
    FEI Number
    2183416
    Product Code
    KCM
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 30, 2023
    Posted
    June 9, 2023
    Address
    11750 12th Ave S, Burnsville, MN, 55337-1297

    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.

    Action

    Apothecary Products notified customers on 03/31/2023 via email. Customers were instructed to immediately check inventory and discard the affected units, notify customers if further distributed, and complete and return the Customer Response Acknowledgement Notification.

    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