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


    Alpina Productos Alimenticios
    Bogota , CO                                    FLA-DO  J50-0103416-2/3/1
    21RCT05   MANGOES PUREE
                        09-JUN-2008                        LABELING

    C.I. AGROFRUT S.A.
    Medellin Co-Ant, CO none                       FLA-DO  900-0053477-7/2/3
    21GGD99   FROZEN LULO PULP 5 CARTONS
                        17-JUN-2008                        PESTICIDE

    Lafrancol S.A.
    Cali , CO                                      NOL-DO  112-1364424-1/1/1
    65PCA02   943740675369 Eroxim (Sildenafil 100 mg)
                        30-JUN-2008                        UNAPPROVED