Refusal Actions by FDA as Recorded in OASIS for Argentina

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


    Eco Holding S.R.L.
    Buenos Aires , AR 1059                         SEA-DO  113-4159356-1/1/1
    20QGH01   CTNS DRIED APPLES
                        08-JAN-2008                        PESTICIDES

    Eco Holding S.R.L.
    Buenos Aires , AR 1059                         SEA-DO  113-4159356-1/2/1
    21HGH03   CTNS DRIED CHEERIES
                        08-JAN-2008                        PESTICIDES

    Lab Pharma Del Plata Srl
    Belgrano , AR 3100                             NOL-DO  112-0836572-9/3/1
    56BAB03   955736322758 /AMOXICILIN
                        10-JAN-2008                        UNAPPROVED

    Lab Rontag Roberto Busnelli
    Buenos Aires , AR                              NOL-DO  112-7648100-1/1/1
    61UCB05   857833319251       TAMOXIFENO
                        13-JAN-2008                        UNAPPROVED