Refusal Actions by FDA as Recorded in OASIS for Australia

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason


    Johnson & Johnson Pacific
    Caringbah,Australia , AU                       NYK-DO  AEK-9118589-8/1/1
    60LAY01   NUROFEN TABLETS
                        08-JUL-2008                        NOT LISTED
                                                           UNAPPROVED

    The Buderim Ginger Growers' Co-Operative Assn. Ltd.
    Yandina , AU 4562                              SAN-DO  521-0060534-5/4/1
    25NGF24   GREEN GINGER PUREE
                        10-JUL-2008                        NO PROCESS

    LAHIDY PTY LTD
    GEELONG AU-VI, AU 3220                         NYK-DO  H67-1315985-2/2/1
    16YAH07   DRIED FISH MAW
                        23-JUL-2008                        FILTHY

    Pfizer Propriety Limited
    West Ryde NSW, AU 2114                         CIN-DO  UPS-1676643-6/1/4
    56ICA76   ZITHROMAX/NO RX/NO ID/PER USE
                        30-JUL-2008                        UNAPPROVED