Refusal Actions by FDA as Recorded in OASIS for Colombia

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


    LABORATORIOS VIDASTEVIA LTDA
    BOGOTA CO-DC, CO 001                           FLA-DO  HG8-0114278-4/1/1A
    45TG-99   Vida Stevia Sweet
                        03-MAR-2008                        UNSAFE ADD

    LABORATORIOS VIDASTEVIA LTDA
    BOGOTA CO-DC, CO 001                           FLA-DO  HG8-0114278-4/1/1B
    45TG-99   Vida Stevia Sweet
                        03-MAR-2008                        UNSAFE ADD

    LABORATORIOS VIDASTEVIA LTDA
    BOGOTA CO-DC, CO 001                           FLA-DO  HG8-0114278-4/1/2
    45TG-99   NATURAL SWEET FROM STEVIA HERBS
                        03-MAR-2008                        UNSAFE ADD

    Pfizer
    Bogota , CO                                    ATL-DO  XXX-0151423-2/1/7
    60LDA01   Sinutab capsules
                        13-MAR-2008                        PERSONALRX