BEUDAMED
    FDA Enforcement Class II Terminated

    Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.

    Recall: Z-1953-2015 · Reported July 8, 2015

    Enforcement

    Recall Number
    Z-1953-2015
    Event ID
    71129
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sheffield Pharmaceuticals, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 8, 2015
    Initiation Date
    April 27, 2015
    Classification Date
    July 2, 2015
    Termination Date
    June 10, 2016
    Address
    170 Broad St, New London, CT, 06320-5313, United States

    Description

    Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.

    Reason

    Recovery of high count of gram positive rods including single colonies of B. cepacia.

    Code Info

    Lot Numbers: 40131 EXP 01/18 ; 40132 EXP 01/18; 40141 EXP 01 /18

    Distribution

    Worldwide Distribution -- CA, NJ, FL, PR, NJ, MI, NY, NC, FL, IL, GA, MN, KS, and NC; and, the countries of Jamaica and Georgia.

    Quantity

    37,636 pieces