Refusal Actions by FDA as Recorded in OASIS for El Salvador

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


    Medicamentos Corporacion
    unknown , SV                                   ATL-DO  XXX-0151423-2/1/5
    56BDR03   Amoxicillina MK (Trihydrate) 250mg/5mL Powder for Suspension
                        13-MAR-2008                        PERSONALRX

    Laboratorios Lopez
    C.A. , SV                                      ATL-DO  XXX-0151441-4/1/7
    54AEY15   Pulmo Calcio (Vitaminado Injectable) - 5mL
                        13-MAR-2008                        NO ENGLISH
                                                           LABELING

    Farmacaps
    Unknown , GT                                   ATL-DO  XXX-0151441-4/1/8
    62GDB18   Diclofenac Sodico (50 mg) tablets
                        13-MAR-2008                        NOT LISTED
                                                           NO ENGLISH

    Biokemical de El Salvador
    unknown , SV                                   ATL-DO  XXX-0151788-8/1/1A
    54YCY99   DESESSTRESS 15 viales vitamin B-12 liquid
                        13-MAR-2008                        NO ENGLISH
                                                           HEALTH C

    El Salvador por Quimica Industrial
    Unknown , SV                                   ATL-DO  XXX-0151788-8/1/1B
    54YCY99   Gluta-Phos Revitaliza  15 viales vitamin B-12 liquid
                        13-MAR-2008                        NO ENGLISH
                                                           NUTRIT LBL

    El Salvador por Quimica Industrial
    Unknown , SV                                   ATL-DO  XXX-0151788-8/1/1C
    54YCY99   Ultra Doceplex B15 liquid packs of Complex B + B12+B15 Vitam
                        13-MAR-2008                        NUTRIT LBL
                                                           HEALTH C

    Billca S.A. de C.V.
    San Salvador SV-SS, SV n/a                     ATL-DO  XXX-0151788-8/1/1D
    54YCY99   Anemiasin Forte Antioxident
                        13-MAR-2008                        FALSE
                                                           NO ENGLISH

    Biokemical de El Salvador
    unknown , SV                                   ATL-DO  XXX-0151788-8/1/1E
    54YCY99   Artribion Vitaminado Contra el Dolor- Artritis inflamcion y
                        13-MAR-2008                        FALSE
                                                           NO ENGLISH

    Laboratorios Vidos
    Unknown , SV                                   ATL-DO  XXX-0151788-8/1/1G
    91D--IF   Bactrizole Balsanico Forte Suspension
                        13-MAR-2008                        DIRECTIONS
                                                           LACKS FIRM

    LOPEZ MAGA?A S.A. DE C.V.
    SAN SALVADOR SV-SS, SV 404                     ATL-DO  XXX-0151788-8/1/1H
    91D--IF   BACZOL ant-flu  antigripal suspension
                        13-MAR-2008                        DIRECTIONS

    LOPEZ MAGA?A S.A. DE C.V.
    SAN SALVADOR SV-SS, SV 404                     ATL-DO  XXX-0151788-8/1/1I
    91D--IF   BACZOL expectorant suspension
                        13-MAR-2008                        DIRECTIONS

    Biokemical de El Salvador
    unknown , SV                                   ATL-DO  XXX-0151788-8/1/1P
    54YCY99   Vitamins stimulante of the appetite
                        13-MAR-2008                        LACKS FIRM
                                                           NO ENGLISH