BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1953-2015 · Initiated April 27, 2015

    Recall

    Recall Number
    Z-1953-2015
    Event Number
    71129
    Firm
    Sheffield Pharmaceuticals, LLC
    FEI Number
    1210513
    Product Code
    MMS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 27, 2015
    Posted
    July 2, 2015
    Terminated
    June 10, 2016
    Address
    170 Broad St, New London, CT, 06320-5313

    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.

    Action

    A letter was sent to inform customers of the voluntary recall of Sheffield Pharmaceuticals Lubri-Gel Personal Lubricant Jelly. The letter described the issue and asked customers to quarantine all related inventory immediately and provide their inventory counts on the specific lots. Questions or concerns related to the recall or letter can be directed to James Turner at [email protected].

    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