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


    Bio Medical Research
    Galway , IE                                    CIN-DO  UPS-1279307-9/1/1
    89I--PF   TOTAL BODY MASSAGE UNIT
                        20-JUN-2008                        FAILS STD
                                                           DIRECTIONS

    Merck Sharp & Dohme Ltd.
    Clonmel, Co. Tipperary , IE 1234               CIN-DO  UPS-0379063-8/1/1
    63EIY30   TIROFIBAN - FOR FUTHER MANUFACTURING - NDC #00006-3739-FOR A
                        30-JUN-2008                        DIRECTIONS