BEUDAMED
    FDA Enforcement Class II Terminated

    KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.

    Recall: Z-0874-2013 · Reported March 6, 2013

    Enforcement

    Recall Number
    Z-0874-2013
    Event ID
    64322
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mc-NEIL-PPC, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 6, 2013
    Initiation Date
    January 25, 2013
    Classification Date
    February 22, 2013
    Termination Date
    April 11, 2014
    Address
    199 Grandview Rd, N/A, Skillman, NJ, 08558-1311, United States

    Description

    KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.

    Reason

    This product is not cleared for marketing in the US.

    Code Info

    Carton: 380040087149 Case Code: 008714 V05 Outer case UPC Code: 103800400871460055 Outer case Display UPC Code: 00380041153300

    Distribution

    Nationwide Distribution.

    Quantity

    750,264 units