BEUDAMED
    FDA Recall Terminated

    Detachol adhesive remover, 4 fl oz (118 mL), Marketed by Eloquest Healthcare, Inc., a Ferndale Pharma Group company, Manufactured by Ferndale Laboratories, Inc., Ferndale, MI 48220 U.S.A.

    Recall: Z-0413-2011 · Initiated July 7, 2010

    Recall

    Recall Number
    Z-0413-2011
    Event Number
    56580
    Firm
    Ferndale Laboratories, Inc.
    FEI Number
    1811212
    Product Code
    KOX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 7, 2010
    Posted
    October 26, 2010
    Terminated
    March 2, 2011
    Address
    780 W 8 Mile Rd, Ferndale, MI, 48220

    Description

    Detachol adhesive remover, 4 fl oz (118 mL), Marketed by Eloquest Healthcare, Inc., a Ferndale Pharma Group company, Manufactured by Ferndale Laboratories, Inc., Ferndale, MI 48220 U.S.A.

    Reason

    There is a defect on the neck surface of the bottles, causing bottles to leak. Bottle defect may potentially cause contamination of solvent stored in bottles.

    Action

    Ferndale Pharma Group issued an Urgent Medical Device Recall letter dated July 7, 2010 to customers identifying the affected product. Customers were instructed to identify and quarantine all affected product and return it to Ferndale Laboratories for a credit. Customers are requested to complete and return an enclosed response form. Customers can contact Ferndale at 800-621-6003.

    Distribution

    Nationwide Distribution: Throughout the US.

    Quantity

    55,000 bottles