BEUDAMED
    FDA Recall Terminated

    Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialysis Grade 2 As an API or excipient in the manufacture of Medical Devices and Drugs

    Recall: Z-1811-2013 · Initiated June 11, 2013

    Recall

    Recall Number
    Z-1811-2013
    Event Number
    65686
    Firm
    Church & Dwight Inc
    FEI Number
    2280705
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    June 11, 2013
    Posted
    July 25, 2013
    Terminated
    June 30, 2015
    Address
    469 N Harrison St, Princeton, NJ, 08540-3510

    Description

    Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialysis Grade 2 As an API or excipient in the manufacture of Medical Devices and Drugs

    Reason

    Church and Dwight Co., Inc. has initiated a recall for Sodium Bicarbonate, USP produced by the Old Fort, OH Sodium Bicarbonate Production facility due to metal and other contamination.

    Action

    Church and Dwight Inc., issued an Urgent Recall letter dated June 11, 2013, and return response form to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to quarantine and return the affected product. For questions regarding this recall call 609-279-7748.

    Distribution

    Nationwide Distribution including IL, PA, IN, OH, MI, TN, TX, MN, MO, NJ, KY,and MD.

    Quantity

    234 sacks at 2500 lbs. each of Dialysis Grade 1.5 ; 880 bags at 50 lbs. each of Dialysis Grade 2