Refusal Actions by FDA as Recorded in OASIS for Costa Rica

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


    3101466409 S.A. (Mbe)
    San Josesan Jose , CR 09000                    CIN-DO  UPS-1129133-1/1/1
    60RCA16   DUROMIN/NO RX/NO ID/PER USE
                        10-JUN-2008                        UNAPPROVED