BEUDAMED
    FDA Recall Terminated

    Product is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle.

    Recall: Z-0398-2007 · Initiated September 25, 2006

    Recall

    Recall Number
    Z-0398-2007
    Event Number
    36458
    Firm
    Belcher Pharmaceuticals Inc.
    FEI Number
    3033007964
    Product Code
    FRO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 25, 2006
    Posted
    February 7, 2007
    Terminated
    July 22, 2008
    Address
    12393 Belcher Rd., Interlaken Commerce Ctr # 420, Largo, FL, 33773

    Description

    Product is Mucotrol Concentrated Oral Gel Wafer contained in HDPE Bottle.

    Reason

    Processing and cleaning process validation were not completed before production. Product had some GMP failures related to the quality system.

    Action

    Consignees were notified of recall via letter dated 09/25/2006.

    Distribution

    Nationwide.

    Quantity

    1097 bottles