BEUDAMED
    FDA Recall Terminated

    Harleco May and Grunwald's Stain; 0.17% w/v; Methanol Solution UN1230; EMD Chemicals Inc. An Affilifate of Merck KGaA Damstadt, Germany; 480 South Democrat Road; Gibbstown, NJ 08027; 1 liter and 4 liter poly bottles

    Recall: Z-0133-2008 · Initiated July 30, 2007

    Recall

    Recall Number
    Z-0133-2008
    Event Number
    39354
    Firm
    EMD Chemicals Inc
    FEI Number
    2244894
    Product Code
    KQC
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    July 30, 2007
    Posted
    November 3, 2007
    Terminated
    December 26, 2007
    Address
    480 S Democrat Rd, Gibbstown, NJ, 08027-1239

    Description

    Harleco May and Grunwald's Stain; 0.17% w/v; Methanol Solution UN1230; EMD Chemicals Inc. An Affilifate of Merck KGaA Damstadt, Germany; 480 South Democrat Road; Gibbstown, NJ 08027; 1 liter and 4 liter poly bottles

    Reason

    Out of Spec -- The Batch (Lot) was incorrectly released after being rejected for out of specification of high azure and eosin absorbance at the end of the run and particulate matter at the end of the run.

    Action

    EMD Chemicals via fax and mailed an Important Product Recall letter dated 7/30/07. The letter notified end use consignee that after conducting an investigation it has determined that Harleco May and Grunwald's Stain; 0.17% w/v Item #660/75 % 660/85 has unacceptable levels of azure and eosin absorbance and undissolved dye matter. Users were requested to discontinue shipping and return product. Wholesalers were advised this is a Customer Level Product Recall and requested to sub recall product sold after 7/5/07.

    Distribution

    Product was released to 2 distributors; one in the US, one in Canada

    Quantity

    26 units (1 liter), 1 unit (4 liter)