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
Canada UPS-1730160-5 1 1 Du Shondu Burnaby BC, CA V3J1L9 SEA-DO 54AAC99 HERBAL MEDICINE A GIFT FOR MY BROTHER IN LAW 06-AUG-2008 NO ENGLISH UNAPPROVED Australia 112-1526521-9 1 1 Salvator Apotheke Eisenstadt , AU A-7000 NOL-DO 54ABA90 862026828288 VITAMINS 22-AUG-2008 NO ENGLISH Egypt 112-1658193-7 1 1 Glaxo Smith Kline Sae Co. Cairo , EG NOL-DO 54ACE99 963998989561 MULTI VITAMINS 21-AUG-2008 LIST INGRE NUTRIT LBL Japan HD8-0090184-9 1 1 Japan Bioproducts Industry Co Ltd Tokyo , JP LOS-DO 54ACH01 DIETARY SUPPLEMENT - 100% AMINO ACIDS (EXTRACTED FROM HUMAN 14-AUG-2008 POISONOUS UNAPPROVED Brazil 112-1454990-2 1 1 FLORA 7 ERVAS PRODUTOS NATURAIS IND COM EXP IMP LTDA HORTOLANDIA BR-SP, BR 13187-041 NOL-DO 54ACY99 855350416457 SUPPLEMENTS 21-AUG-2008 DIETARYLBL LACKS FIRM China UPS-2126180-3 1 1 Northeast General Pharmaceutical Factory Shenyang Liaoning, CN 1234 CIN-DO 54AFS13 ASCORBIC ACID, FOR RX COMPOUNDING, NDC# 054937-0100 21-AUG-2008 DRUG GMPS France 554-3961109-0 1 1 Adisseo France S.A.S Commentry FR-03, FR 03600 LOS-DO 54AMY01 MICROVIT A SUPRA 1000 - VITAMIN A;ANML DIET SUPL;NEC 27-AUG-2008 NEW VET DR France 554-3961109-0 2 1 Adisseo France S.A.S Commentry FR-03, FR 03600 LOS-DO 54AMY01 MICROVIT A PROMIX - VITAMIN A;ANML DIET SUPL;NEC 27-AUG-2008 NEW VET DR France 554-3961109-0 3 1 Adisseo France S.A.S Commentry FR-03, FR 03600 LOS-DO 54AMY99 MICROVIT -VITAMIN, N.E.C.;ANML DIET SUPL;NEC 27-AUG-2008 NEW VET DR Mexico 112-1416960-2 1 1 Pedrosa Central De Droga Socieda Naucalpan , MX 53348 NOL-DO 54AYY99 864736932150 DIETARY SUPP 20-AUG-2008 NO ENGLISH India 112-1761617-9 1 5 Sanat Products Limited Delhi , IN NOL-DO 54AYY99 SHILAJIT 21-AUG-2008 LIST INGRE POISONOUS India 112-1761617-9 1 4 M S Dabar India Ltd Panth Nagar Uth , IN NOL-DO 54AYY99 HIMCOLIN GEL 21-AUG-2008 FORBIDDEN India 112-1761617-9 1 3 Himalaya Drug Co Priv Ltd Bangalore-2 , IN 562123 NOL-DO 54AYY99 TENTEX 21-AUG-2008 LIST INGRE India 112-1761617-9 1 2 M S Sribaidayanathaurved Road Nagpur , IN NOL-DO 54AYY99 BAIDYANTH CHAMPRESH 21-AUG-2008 LIST INGRE Lebanon 112-1884082-8 1 1 A Amana Care Sarl Beirut , LB NOL-DO 54AYY99 856017732715 SUPPLEMENTS 22-AUG-2008 LIST INGRE LACKS FIRM China EJ8-0816444-9 2 1 Two Way Trading Co., Kowloon , HK SAN-DO 54ECB99 HSIAO KEH CHUAN CAPSULES 14-AUG-2008 UNSAFE COL China 349-0898769-5 1 1 Huzhou Daybreak Imp & Exp Co., Ltd. Huzhou , CN LOS-DO 54FAR99 ASIA GINSENG, CHINESE YAM, PORIA, SCHIZANDRA, DUDZU, CHINESE 04-AUG-2008 UNSAFE ADD China HR7-0191990-7 2 1 Whale Emperor Limited Hong Kong HK-NA, HK 000 LOS-DO 54FAT12 RED GINSENG 13-AUG-2008 NOT LISTED UNAPPROVED China HR7-0191990-7 3 1 B Whale Emperor Limited Hong Kong HK-NA, HK 000 LOS-DO 54FAT99 Paper Packaging box 13-AUG-2008 LIST INGRE Japan 510-7177515-2 1 1 Jilin Province Hongjiu Biotech Co., Ltd. Dalian , CN 116001 LOS-DO 54FBB12 PANAX GINGSENG EXTRACT POWDER 27-AUG-2008 PESTICIDES China 349-0900723-8 1 1 Huisong Pharmaceuticals Hangzhou , CN LOS-DO 54FBR12 PANAX GINSENG EXTRACT POWDER 13-AUG-2008 PESTICIDES China 112-2913561-4 1 1 Nutraland Ltd Shanghai , CN 200233 CHI-DO 54FBT99 TRANS-RESVERATROL 50%(HPLC) 12-AUG-2008 UNSFDIETSP UNSAFE ADD POISONOUS China W33-0986643-0 1 114 Va Kei Agricultual Commodities Processing Co Guangdong , CN LOS-DO 54FBY99 TRICHOSANTHES KIRILOWII 6 CTNS. 20-AUG-2008 FILTHY United States UPS-1058158-3 1 1 D Barmensen Inc Denver, CO 80239-2338 NYK-DO 54FCA99 15 Vazomyne Tablets. 06-AUG-2008 UNAPPROVED United States 315-9250252-5 1 1 Aim Usa Nampa, ID 83687-3102 LOS-DO 54FCH99 HERBAL CLEANSING SUPPLEMENT 01-AUG-2008 NOT LISTED UNAPPROVED United States 315-9250252-5 1 2 Aim Usa Nampa, ID 83687-3102 LOS-DO 54FCH99 COMPOSURE SOOTHING HERBAL SUPPLEMENT 01-AUG-2008 NOT LISTED UNAPPROVED Canada 551-6847985-0 1 1 Homeolab Inc. Montreal QC, CA H1N2H2 NWE-DO 54FCL99 KIDS 0-9 TEETHING SOLUTION 25M 04-AUG-2008 NO ENGLISH Canada 551-6847985-0 2 1 Homeolab Inc. Montreal QC, CA H1N2H2 NWE-DO 54FCL99 KIDS 0-9 CALM SYRUP 100ML 04-AUG-2008 NO ENGLISH United Arab Emirates WUG-0142407-5 4 5 Dabur International Limited Jebel Ali , AE LOS-DO 54FCL99 DABUR MADHUVADI 13-AUG-2008 UNAPPROVED United Arab Emirates WUG-0142407-5 14 1 Dabur International Limited Jebel Ali , AE LOS-DO 54FCL99 JANAM GHUNTI 13-AUG-2008 UNSFDIETSP Canada 551-6866069-9 41 1 Homeolab Inc. Montreal QC, CA H1N2H2 NWE-DO 54FCL99 KIDS 0-9 EARACHE SOLUTION 25ML 19-AUG-2008 NO ENGLISH Canada 551-6866069-9 42 1 Homeolab Inc. Montreal QC, CA H1N2H2 NWE-DO 54FCL99 KIDS 0-9 COLIC SOLUTION 25ML 19-AUG-2008 NO ENGLISH Canada 551-6866069-9 43 1 Homeolab Inc. Montreal QC, CA H1N2H2 NWE-DO 54FCL99 KIDS 0-9 COUGH & COLD SYRUP 10 19-AUG-2008 NO ENGLISH Venezuela 112-1453803-8 1 2 Mrw Caracas , VE NOL-DO 54FFL99 929420366112 ARNICA 21-AUG-2008 LACKS FIRM LABELING United States UPS-1058158-3 1 1 A Barmensen Inc Denver, CO 80239-2338 NYK-DO 54FYJ99 2.0 oz tube of MAXODERM 06-AUG-2008 UNAPPROVED United States UPS-1058158-3 1 1 B Barmensen Inc Denver, CO 80239-2338 NYK-DO 54FYJ99 .2 oz packetes of Maxoderm 06-AUG-2008 UNAPPROVED Korea, Republic Of (South) CAY-1007195-6 31 1 SEO KANG TRADING CO.,LTD SEOUL KR-11, KR 130-864 LOS-DO 54FYY55 SINOMENIUM STEM AND RHIZOME 26-AUG-2008 EPHEDALK New Zealand 112-1746313-5 1 1 Shop New Zealand Auckland , NZ NOL-DO 54YCB99 VIta Fit-Growth hormone releaser 21-AUG-2008 HEALTH C France 322-6278982-2 4 1 Pierre Fabre Dermo Cosmetique Castres Cedex , FR 81106 NOL-DO 54YCE10 VITALFAN VITALITY 22-AUG-2008 UNSAFE COL China 112-2535286-6 1 1 Kunming DaLi Industry & Trade Co., Ltd Kunming CN-53, CN 650118 SEA-DO 54YCF99 LI DA DAI DAI HUA CAPSULES 21-AUG-2008 DIRECTIONS Taiwan BTF-0015272-4 1 1 Young Discover Trading Co Shalu Township , TW CHI-DO 54YCL08 Q10 COLLAGEN BEAUTY DRINK 25-AUG-2008 LIST INGRE DIETARYLBL NO ENGLISH NUTRIT LBL Japan 427-7104152-4 1 1 Genome Factory No.2 Furano-Shi , JP 076-0002 SAN-DO 54YCL99 NANOJELLY 1 (Carrot & Vitamin) 19-AUG-2008 LIST INGRE LACKS FIRM LACKS N/C NUTRIT LBL NEEDS FCE NO PROCESS Japan 427-7104152-4 1 2 Genome Factory No.2 Furano-Shi , JP 076-0002 SAN-DO 54YCL99 NANOJELLY 2 (Carrot & Collagen) 19-AUG-2008 LIST INGRE LACKS FIRM LACKS N/C NUTRIT LBL NEEDS FCE NO PROCESS Japan 427-7104152-4 1 3 Genome Factory No.2 Furano-Shi , JP 076-0002 SAN-DO 54YCL99 NANOJELLY 3 (Carrot & Hyaluronic Acid) 19-AUG-2008 LIST INGRE LACKS FIRM LACKS N/C NUTRIT LBL NEEDS FCE NO PROCESS Japan 427-7104152-4 1 4 Genome Factory No.2 Furano-Shi , JP 076-0002 SAN-DO 54YCL99 NANOJELLY 4 (Carrot & Pollen) 19-AUG-2008 LIST INGRE LACKS FIRM LACKS N/C NUTRIT LBL NEEDS FCE NO PROCESS Japan 427-7104152-4 1 5 Genome Factory No.2 Furano-Shi , JP 076-0002 SAN-DO 54YCL99 NANOJELLY 5 (Carrot & Calcium) 19-AUG-2008 LIST INGRE LACKS FIRM LACKS N/C NUTRIT LBL NEEDS FCE NO PROCESS Japan 427-7104152-4 1 6 Genome Factory No.2 Furano-Shi , JP 076-0002 SAN-DO 54YCL99 NANOJELLY 6 (Carrot & Royal Jelly) 19-AUG-2008 LIST INGRE LACKS N/C LACKS FIRM NUTRIT LBL NEEDS FCE NO PROCESS Japan 427-7104152-4 1 7 Genome Factory No.2 Furano-Shi , JP 076-0002 SAN-DO 54YCL99 NANOJELLY 7 (Carrot & Lutein) 19-AUG-2008 LIST INGRE LACKS FIRM LACKS N/C NUTRIT LBL NEEDS FCE NO PROCESS Japan 427-7104152-4 1 8 Genome Factory No.2 Furano-Shi , JP 076-0002 SAN-DO 54YCL99 NANOJELLY Hawaiian Rainbow Pack 19-AUG-2008 LIST INGRE LACKS N/C LACKS FIRM NUTRIT LBL NEEDS FCE NO PROCESS Canada UPS-0769153-2 1 1 Atrium Innovations Inc Quebecquebec QUEBEC, CA G1P4P5 NYK-DO 54YCL99 FUSION ENERGY BERRY SHOT, LIQUID DIETARY SUPPLEMENT (6+HR EN 25-AUG-2008 LIST INGRE United States 112-1491206-8 1 1 Hvl Inc. Pittsburgh, PA 15205-9742 NOL-DO 54YCY99 799272835407 CREADEX SUPPLEMENT 21-AUG-2008 HEALTH C Australia AEK-7743756-0 1 1 Charlie Torrensville , AU LOS-DO 54YCY99 PROSOLUTION GEL BOXES 21-AUG-2008 FALSE Mexico AEK-9527566-1 1 1 Capslim Haciendas De Coyoacan , MX 04970 CIN-DO 54YEE99 PROVITAMINS 13-AUG-2008 NO ENGLISH