Refusal Actions by FDA as Recorded in OASIS for Hungary

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Chinoin Pharmaceutical & Chemical Works Private Co. Ltd. Budapest , HU H-1045 MIN-DO 605-4532496-8/2/1 66SCS45 ALPROSTADIL (VASODILATOR);HUMAN - RX/SINGLE INGREDIENT;ACTIV 08-AUG-2008 UNAPPROVED Eminence Organic Skin Care Inc. Vancouver BC, CA V5Y3J6 SEA-DO ARM-0034875-1/11/1 53LG-09 SEVEN HERB TREATMENT 19-AUG-2008 CSTIC LBLG