Refusal Actions by FDA as Recorded in OASIS


   Country of Origin                     Entry #   DOC  Line Suffix
   Manufacture Name
   City / Country or region                                 District
   Product Code        Product Description
                          Date                              Reason
Israel 112-3559308-7 1 1 Novartis Petach Tikva , IL NOL-DO 60CAK53 865108117538/OTRIVIN SPRAY 21-JUL-2008 UNAPPROVED Portugal 112-3465107-6 1 1 Bayer Portugal Sa Carnaxide , PT NOL-DO 60LAA05 791922999996 ASA (Acetylsalicylic Acid) 21-JUL-2008 UNAPPROVED China M21-0737915-0 3 1 Wendt-Chemie Vertriebsges Mbh & Co. Hamburg , DE 22041 FLA-DO 60LAL21 DIPYRONE FOR EXPORT ONLY, PLEASE REFUSE CARGO 02-JUL-2008 UNAPPROVED Australia AEK-9118589-8 1 1 Johnson & Johnson Pacific Caringbah,Australia , AU NYK-DO 60LAY01 NUROFEN TABLETS 08-JUL-2008 NOT LISTED UNAPPROVED Korea, Republic Of (South) U47-0460734-8 44 1 Cosmos Confectionary Co.,Ltd. Gyeonggido , KR NYK-DO 60LAY63 PAS 23-JUL-2008 NOT LISTED UNAPPROVED Mexico AEG-2009913-2 5 1 Mead Johnson De Mexico Sa De Cv Mexico 1 Df , MX SWI-DO 60LBA99 PAIN RELIEVER/FEVER REDUCER, 1CTN-22PCS/CTN-100TABLETS/PC 31-JUL-2008 NOT LISTED India 315-7882213-7 4 1 Mata Amritanandamayi Mission Trust Kerala , IN SAN-DO 60LBJ99 PAIN BALM 10-JUL-2008 NOT LISTED Japan AEK-9677686-5 1 1 Satoru Yoshino Tokyo , JP LOS-DO 60LBJ99 COSMETICS 14-JUL-2008 NOT LISTED UNAPPROVED India AYG-1001538-1 15 1 Aabhar International Mumbai , IN 400 077 SAN-DO 60LBJ99 MOVE CREAM 19-JUL-2008 NOT LISTED DIRECTIONS UNAPPROVED India AYG-1001538-1 16 1 Aabhar International Mumbai , IN 400 077 SAN-DO 60LBJ99 IODEX CREAM 19-JUL-2008 NOT LISTED DIRECTIONS UNAPPROVED China FS2-8010297-1 4 1 Xiamen Traditional Chinese Medicine Co., Ltd. Xiamen, Fujian CN-35, CN 361009 NYK-DO 60LBO04 MA YING LONG HEMORRHOID OINTMENT 10-JUL-2008 NOT LISTED UNAPPROVED China FS2-8010297-1 4 2 Xiamen Traditional Chinese Medicine Co., Ltd. Xiamen, Fujian CN-35, CN 361009 NYK-DO 60LBO04 MA YING LONG HMORRHOID SUPPOSITORY 10-JUL-2008 NOT LISTED UNAPPROVED China FS2-8010297-1 4 3 Xiamen Traditional Chinese Medicine Co., Ltd. Xiamen, Fujian CN-35, CN 361009 NYK-DO 60LBO04 STOMACH SOOTHING GRANULAR 10-JUL-2008 NOT LISTED UNAPPROVED India 231-5221450-1 1 1 SRI Krishna Pharmaceuticals LTD Andhra Pradesh , IN 500 039 NYK-DO 60LBS01 ACETAMINOPHEN GRANULES DC 90% 24-JUL-2008 DIRECTIONS Germany AEK-9506847-0 1 1 Bin Seena Health Limited London , GB W22HZ CIN-DO 60LCA69 PERSONAL MEDICATION - ZYDOL SR 100MG 10/RX 21-JUL-2008 UNAPPROVED Nigeria XXX-0154562-4 1 1 H Global Ind. Nigeria Ltd Benin City , NG SWI-DO 60LDJ99 Aboniki Balm 07-JUL-2008 DIRECTIONS UNAPPROVED China DS9-0167272-7 1 1 B Caremax Co Ltd Suzhou , CN 215008 NYK-DO 60LJY99 Insect Sting Relief Pads 28-JUL-2008 NOT LISTED UNAPPROVED Costa Rica 112-3142105-1 1 1 Newport Pharmaceutical San Jose , CR NOL-DO 60RDA19 852182433667 Sibutramina 21-JUL-2008 NO ENGLISH UNAPPROVED India 300-1971547-1 5 1 Thakar Exports Trinagar-Delhi , IN 110035 CHI-DO 60SBL09 TELEPHONE ISABGOL 08-JUL-2008 NOT LISTED UNAPPROVED India 300-1971547-1 6 1 Thakar Exports Trinagar-Delhi , IN 110035 CHI-DO 60SBL09 TELEPHONE ISABGOL 08-JUL-2008 NOT LISTED UNAPPROVED India AYG-1001538-1 17 1 Aabhar International Mumbai , IN 400 077 SAN-DO 60SBR99 ENO SALT 19-JUL-2008 NOT LISTED China M21-0737915-0 6 1 Wendt-Chemie Vertriebsges Mbh & Co. Hamburg , DE 22041 FLA-DO 60SCA23 METOCLOPRAMIDE FOR EXPORT ONLY, PLEASE REFUSE MERCHANDISE 02-JUL-2008 UNAPPROVED China M21-0737782-4 1 1 Research Pharmaceutical Co Ltd Shanghai , CN FLA-DO 60WCA01 ALBENDAZOLE "FOR EXPORT ONLY" PLEASE REFUSE MERCHANDISE. 14-JUL-2008 UNAPPROVED