BEUDAMED
    FDA Recall Terminated

    S/P Orange 50g Glucose Tolerance Beverage, 10 oz glass bottles, 12 bottles/case, labeled in part ***Cardinal Health McGaw Park, IL 60085-6787 USA*** For prescription use only. Product is used in support of diagnostics testing for hyperglycemia and hypoglycemia.

    Recall: Z-0278-2009 · Initiated April 23, 2008

    Recall

    Recall Number
    Z-0278-2009
    Event Number
    48739
    Firm
    Nerl Diagnostics LLC
    FEI Number
    3002879536
    Product Code
    MRV
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 23, 2008
    Posted
    November 4, 2008
    Terminated
    November 26, 2012
    Address
    3800 Dillon St, Baltimore, MD, 21224-5248

    Description

    S/P Orange 50g Glucose Tolerance Beverage, 10 oz glass bottles, 12 bottles/case, labeled in part ***Cardinal Health McGaw Park, IL 60085-6787 USA*** For prescription use only. Product is used in support of diagnostics testing for hyperglycemia and hypoglycemia.

    Reason

    Beverage may contain glass particles.

    Action

    The recalling firm notified distribution centers by letter dated 04/23/08 and advised of a single report of glass found in a bottle. The notifications further advised distributors to quarantine referenced product, notify their customers and return the enclosed reply form. Distributors were requested to return or destroy product for replacement. Please contact NERL Diagnostics, LLC at 1-401-824-2046 for assistance.

    Distribution

    Nationwide.

    Quantity

    25908 bottles