Refusal Actions by FDA as Recorded in OASIS for Egypt

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


    El Rashidi El Mizan Confectionery Co.
    6th of October City EG-NOTA, EG NONE           CHI-DO  J89-0086771-6/1/1
    23MHT01   SESAME PASTE;NON FLEX PLAS;PKGD FOOD;TAHINA
                        05-DEC-2007                        SALMONELLA

    Arab Drug Co
    El Sawah Amiria , EG                           NOL-DO  112-0243448-9/1/1
    62GCB42   954558829759.INDOMETHACIN 100MG
                        06-DEC-2007                        UNAPPROVED

    Maghrabi For Optics
    Cairo , EG                                     NOL-DO  112-0311094-8/1/1
    86N--JH   955503925826 /EYEGLASSES
                        10-DEC-2007                        NOT LISTED
                                                           NOT IMPACT

    Glaxosmith Kline
    Cairo , EG                                     NOL-DO  112-0361683-7/1/1
    62GCA86   955503922140.ZYLORIC 100MG
                        11-DEC-2007                        UNAPPROVED

    Pfizer Egypt
    Caire , EG                                     NOL-DO  112-0361683-7/1/3
    62GCB42   955503922140.BONIDON 75MG
                        11-DEC-2007                        UNAPPROVED

    Pfizer Egypt
    Caire , EG                                     NOL-DO  112-0361683-7/1/4
    60SCB25   955503922140 RANI
                        11-DEC-2007                        UNAPPROVED

    Merck Sharp & Dohme Scientific Office
    Cairo , EG                                     NOL-DO  112-0361683-7/1/2
    63NCB03   955503922140.URECHOLINE 5.MG
                        11-DEC-2007                        UNAPPROVED

    Eipico
    Cairo , EG                                     NOL-DO  112-0331714-7/1/1
    62KCY10   955503926568 OMRPRAZOLE
                        20-DEC-2007                        UNAPPROVED