Refusal Actions by FDA as Recorded in OASIS for Belgium

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


    Vygon, S.A.
    Ecouen  , FR 95440                             FLA-DO  K51-0064258-3/5/1
    80F--OS   CATHETERS
                        11-AUG-2008                        REGISTERED

    Wettern Plant
    Wettern , BE                                   NYK-DO  KH5-0035173-0/1/1
    62ICS30   6-MERCAPTOPURINE USP; NDC#50923-0458-0; USE: RX
                        18-AUG-2008                        DIRECTIONS

    Terumo
    Leuven , BE                                    NOL-DO  112-1577726-2/2/1
    80M--WV   958087650779 HYPODERMIC NEEDLE
                        22-AUG-2008                        NOT LISTED
                                                           RX DEVICE

    Ontex N.V.
    Buggenhout  , BE 9255                          FLA-DO  BIP-0013426-4/1/1
    78E--YQ   ADULT BRIEFS MD- NOT FOR RESALE/FOR EXHIBITION
                        28-AUG-2008                        REGISTERED

    Ontex N.V.
    Buggenhout  , BE 9255                          FLA-DO  BIP-0013426-4/1/2
    78E--YQ   ADULT BRIEFS LG/NOT FOR RESALE-FOR EXHIBITION
                        28-AUG-2008                        REGISTERED

    Ontex N.V.
    Buggenhout  , BE 9255                          FLA-DO  BIP-0013426-4/1/3
    78E--YQ   ADULT UNDERWEAR (PULLUPS) MD- NOT FOR RESALE- FOR EXHIBITION
                        28-AUG-2008                        REGISTERED

    Ontex N.V.
    Buggenhout  , BE 9255                          FLA-DO  BIP-0013426-4/1/4
    78E--YQ   ADULT UNDERWEAR (PULLUPS) LG- NOT FOR RESALE- FOR EXHIBITION
                        28-AUG-2008                        REGISTERED

    Ontex N.V.
    Buggenhout  , BE 9255                          FLA-DO  BIP-0013426-4/1/5
    78E--YQ   BRIEFS SAMPLE TWIN PACK LG- NOT FOR RESALE-FOR EXHIBITION
                        28-AUG-2008                        REGISTERED