Refusal Actions by FDA as Recorded in OASIS for Israel

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


    Verint Ltd
    Tel Aviv , IL 69710                            NOL-DO  112-0153926-2/8/1B
    95R--ES   712642597138  LASER POINTERS
                        05-DEC-2007                        NON STD

    Dexcel Pharma Technologies Ltd
    Hadera , IL                                    NOL-DO  112-0222460-9/1/1
    62KCA10   658124720780 OMEPRAZOLE
                        06-DEC-2007                        NOT LISTED
                                                           UNAPPROVED

    Bnei Darom
    Bene Darom , IL 79250                          NYK-DO  554-5273024-9/1/1
    24FHT01   GRILLED FROZEN NATURAL EGGPLANT PUREE
                        08-DEC-2007                        UNSAFE COL

    Agrexco Agricultural Export Co., Ltd. (Tranzit Tal)
    Lod IL-NOTA, IL 71100                          NYK-DO  EH1-0156671-7/1/1
    24FFC50   CHERRY TOMATOES
                        11-DEC-2007                        PESTICIDE

    Boot Net Ltd
    Jerusalem , IL 940101                          NOL-DO  112-0506668-4/1/1A
    56DKO41   853037141153 Neo-Predef
                        18-DEC-2007                        PERSONALRX
                                                           UNAPPROVED

    E. L. Erman Cosmetics Mfg
    Ashdod , IL                                    FLA-DO  101-7646846-9/1/1
    53LD-06   FACIAL CREAM SPF 20
                        21-DEC-2007                        NOT LISTED

    Ness Ltd
    Raananna , IL                                  NOL-DO  112-0713361-5/1/1
    84N--UH   NERVE STIMULATOR
                        27-DEC-2007                        NOT LISTED
                                                           NO 510(K)

    Teva Pharmaceutical Industries, LTD.
    Petah Tikva , IL 49510                         NOL-DO  112-0708355-4/1/1
    61NDY29   857809762144 FLUOXETINE 20 MG
                        27-DEC-2007                        UNAPPROVED

    Ness
    Rahanana , IL                                  NOL-DO  112-0676953-4/1/1
    84N--HI   932591715136  CRT Clinician's Medical Equipment (Nerve Stimu
                        27-DEC-2007                        NOT LISTED
                                                           NO 510(K)