Refusal Actions by FDA as Recorded in OASIS for Denmark

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


    Leo Pharma A/S
    Ballerup , DK DK-2750                          FLA-DO  112-3367730-4/2/1
    61WCJ34   865811004677 FUCICORANT
                        16-JUL-2008                        UNAPPROVED

    Danamedic
    Klampenborgklampenborg , DK 2930               CIN-DO  UPS-1161823-6/1/1
    78L--KY   RIGIDITY DEVICE COMPONENTS-PERSONAL USE
                        21-JUL-2008                        DIRECTIONS
                                                           REGISTERED

    Procordia Food Ab
    Eslov Gothenberg, SE 24181                     CHI-DO  224-0802629-6/8/1
    24TCI08   RED CABAGE
                        24-JUL-2008                        NO PROCESS

    Brenntag Biosector A/S
    Frederikssund , DK DK-3600                     NYK-DO  AEK-9119215-9/1/1
    65ANZ99   SAPONIN  QUIL-A
                        28-JUL-2008                        NOT LISTED
                                                           DIRECTIONS

    Haribo Lakrids A/S
    Fakse DK-025, DK DK-4640                       SWI-DO  512-1003900-7/13/1
    33EGT08   CANDY-HARIBO MATADOR MIX
                        30-JUL-2008                        UNSAFE COL
                                                           LACKS N/C