Refusal Actions by FDA as Recorded in OASIS for Spain

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


    Kylolab Srl
    Ceuti , ES                                     LOS-DO  906-0648899-8/1/1
    62IAS13   CHLORAMBUCIL
                        01-JUL-2008                        NOT LISTED

    Sanmel Sl
    Caceres , ES                                   SEA-DO  EE6-2208307-3/10/1
    34EGT03   CHOCOLATE FILLED W/FIG
                        07-JUL-2008                        FILTHY
                                                           NUTRIT LBL