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


    Instituto Biologico Argentino S.A.I.C.
    Buenos Aires , AR 1027                         NOL-DO  112-8795808-8/1/2
    61KCA69   857148597781/SPASMEX 30 MG
                        05-NOV-2007                        UNAPPROVED

    Instituto Biologico Argentino S.A.I.C.
    Buenos Aires , AR 1027                         NOL-DO  112-8795808-8/1/1
    61KCA69   857148597781/SPASMEX 15 MG
                        05-NOV-2007                        UNAPPROVED

    Western Export Srl
    Buenos Aires , AR                              NYK-DO  655-1389996-7/1/1
    20BGH10   RAISINS
                        15-NOV-2007                        STD QUALIT