Refusal Actions by FDA as Recorded in OASIS for Ireland

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


    Bimeda Chemicals Ltd
    Tallaght Co Dublin , IE 24                     LOS-DO  BXE-0009593-3/1/1
    56BKS52   AMOXYCILLIN TRIHYDRATE/ALUGEL NON HUMAN USE
                        08-APR-2008                        UNAPPROVED