Refusal Actions by FDA as Recorded in OASIS for Dominican Republic

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


    Mediamerica Sa
    Los Prados , DO                                NOL-DO  112-4407007-7/1/1
    53LD-99   865083931812  L-Carnitina & Alcachofa (CELLULITE OIL)
                        02-OCT-2008                        CSTIC LBLG
                                                           COSMETLBLG
                                                           COSMETLBLG

    Laboratorios Rowe
    Santo Domingo , DO                             NOL-DO  112-4406516-8/1/1
    61FDA54   865797197143 CIPROFLAXIN 500 MG
                        02-OCT-2008                        UNAPPROVED

    Laboratorios Rowe
    Santo Domingo , DO                             NOL-DO  112-4406516-8/1/2
    66VIP99   865797197143  Imidal 500 MG
                        02-OCT-2008                        UNAPPROVED

    Jose C. Abreu
    Jarabacoa DO-13, DO none                       FLA-DO  DM4-0228534-8/1/4
    24FFC07   BELL PEPPERS
                        06-OCT-2008                        PESTICIDE

    Laboratorios Key C Por A
    Santo Domingo , DO                             FLA-DO  606-0103621-7/4/1
    53EC-99   Crema Negra Miss Key
                        22-OCT-2008                        UNSAFE COL

    Convatec Dominican Republic
    Haina,San Cristobal,Do , DO                    SJN-DO  508-0315508-9/1/1
    78E--ZQ   LITTLE ONES WFR FLEX/ACIVE LIFE PCH
                        28-OCT-2008                        REGISTERED