Refusal Actions by FDA as Recorded in OASIS for Costa Rica

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Montana Del Arco Iris S.A. San Jose , CR SJN-DO 256-0289165-4/1/1 31KYT99 7 BLOSSOMS CALMES NERVES (HERBAL TEA BLEND) 01-APR-2008 DIETARYLBL LACKS N/C NUTRIT LBL UNAPPROVED Montana Del Arco Iris S.A. San Jose , CR SJN-DO 256-0289165-4/1/2 31KYT99 ADELGA-T (HERBAL TEA BLEND) 01-APR-2008 DIETARYLBL INCONSPICU LACKS N/C NUTRIT LBL UNAPPROVED Montana Del Arco Iris S.A. San Jose , CR SJN-DO 256-0289165-4/1/4 31KYT99 DIGEXTIVAN INDIGESTION AND COLICS HERBAL TEA 01-APR-2008 DIETARYLBL INCONSPICU LACKS N/C NUTRIT LBL UNAPPROVED Montana Del Arco Iris S.A. San Jose , CR SJN-DO 256-0289165-4/1/5 31KYT99 DORMY INSOMNIA HERBAL TEA 01-APR-2008 DIETARYLBL INCONSPICU LACKS N/C NUTRIT LBL UNAPPROVED Grupo Pozuelo & Pro G.P.P. S.A., CIUDAD COLON Cr-Sj, CR 6100 LOS-DO 389-0038866-1/1/14 07AGT99 CHIZ BOLZ PRO 17-APR-2008 UNSAFE COL