BEUDAMED
    FDA Recall Terminated

    EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml; 1.0 mg Ethanol in 1 ml, 10 ampules; Item number 68991/95; in vitro diagnostic.

    Recall: Z-1607-2008 · Initiated March 27, 2008

    Recall

    Recall Number
    Z-1607-2008
    Event Number
    47528
    Firm
    EMD Chemicals Inc
    FEI Number
    2244894
    Product Code
    DNN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 27, 2008
    Posted
    September 16, 2008
    Terminated
    September 22, 2008
    Address
    480 S Democrat Rd, Gibbstown, NJ, 08027-1239

    Description

    EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml; 1.0 mg Ethanol in 1 ml, 10 ampules; Item number 68991/95; in vitro diagnostic.

    Reason

    Incorrect concentration: 2 ampules measuring 2.0 mg/ml were found in a lot of 20 ampules of 1.0 mg/ml Ethanol Standard.

    Action

    VWR International and Thermo Fisher Scientific were notified of the recall by e-mail on 3/27/08 and asked to provide end user lists so that recall letters could be sent to each customer. Customers were sent a letter commencing April 3, 2008, by first class mail.

    Distribution

    Nationwide Distribution.

    Quantity

    99 cases (10 ampules per case)