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
United Kingdom 946-0603923-1 6 1 Sara Lee Household & Body Care Slough FN, GB LOS-DO 53BD-01 STRESS RELIEF HERBAL BATH 28-JAN-2008 NOT LISTED Canada WFN-8049506-8 1 1 Korex Canada Limited Etobicoke ON, CA M8Z2J8 NYK-DO 53BH-01 ALPEN BATH SALT 14-JAN-2008 CSTIC LBLG China EG6-1421659-6 5 1 Xiamen Winstar Import & Export Co., Ltd Xiamen , CN NYK-DO 53BH-03 BATH FIZZER 18-JAN-2008 COSM COLOR China 112-8571853-4 1 1 Taizhou Haotian Industrial Zhejiang , CN BLT-DO 53BY-99 SHOWER GEL SET 17-JAN-2008 UNSAFE COL Germany 231-7408047-6 7 1 Schwan Cosmetics Gmbh & Co. KG Heroldsberg , DE 90562 SWI-DO 53CC-02 EARTH EYELINER 02-JAN-2008 COSM COLOR CSTIC LBLG Germany 231-7408047-6 18 3 Schwan Cosmetics Gmbh & Co. KG Heroldsberg , DE 90562 SWI-DO 53CC-02 GUNMETAL EYELINER 02-JAN-2008 COSM COLOR CSTIC LBLG Germany 231-7408047-6 27 1 Schwan Cosmetics Gmbh & Co. KG Heroldsberg , DE 90562 SWI-DO 53CC-02 EARTH EYELINER 02-JAN-2008 COSM COLOR CSTIC LBLG Germany 231-7408047-6 27 2 Schwan Cosmetics Gmbh & Co. KG Heroldsberg , DE 90562 SWI-DO 53CC-02 GUNMETAL EYELINER 02-JAN-2008 COSM COLOR CSTIC LBLG Germany 231-7408047-6 40 1 Schwan Cosmetics Gmbh & Co. KG Heroldsberg , DE 90562 SWI-DO 53CC-02 EARTH EYELINER 02-JAN-2008 COSM COLOR CSTIC LBLG Germany 231-7408047-6 46 1 Schwan Cosmetics Gmbh & Co. KG Heroldsberg , DE 90562 SWI-DO 53CC-02 GUNMETAL EYELINER 02-JAN-2008 COSM COLOR CSTIC LBLG Germany 231-7408047-6 53 1 Schwan Cosmetics Gmbh & Co. KG Heroldsberg , DE 90562 SWI-DO 53CC-02 EARTH EYELINER 02-JAN-2008 COSM COLOR CSTIC LBLG Germany 231-7408047-6 53 2 Schwan Cosmetics Gmbh & Co. KG Heroldsberg , DE 90562 SWI-DO 53CC-02 GUNMETAL EYELINER 02-JAN-2008 COSM COLOR CSTIC LBLG Germany 231-7408047-6 60 1 Schwan Cosmetics Gmbh & Co. KG Heroldsberg , DE 90562 SWI-DO 53CC-02 EARTH EYELINER 02-JAN-2008 COSM COLOR CSTIC LBLG Germany 231-7408047-6 60 3 Schwan Cosmetics Gmbh & Co. KG Heroldsberg , DE 90562 SWI-DO 53CC-02 GUNMETAL EYELINER 02-JAN-2008 COSM COLOR CSTIC LBLG Germany 231-7408047-6 66 1 Schwan Cosmetics Gmbh & Co. KG Heroldsberg , DE 90562 SWI-DO 53CC-02 EARTH EYELINER 02-JAN-2008 COSM COLOR CSTIC LBLG Germany 231-7408047-6 66 3 Schwan Cosmetics Gmbh & Co. KG Heroldsberg , DE 90562 SWI-DO 53CC-02 GUNMETAL EYELINER 02-JAN-2008 COSM COLOR CSTIC LBLG Germany 231-7408047-6 75 1 Schwan Cosmetics Gmbh & Co. KG Heroldsberg , DE 90562 SWI-DO 53CC-02 EARTH EYELINER 02-JAN-2008 COSM COLOR CSTIC LBLG Germany 231-7408047-6 75 2 Schwan Cosmetics Gmbh & Co. KG Heroldsberg , DE 90562 SWI-DO 53CC-02 GUNMETAL EYELINER 02-JAN-2008 COSM COLOR CSTIC LBLG Germany 231-7408047-6 83 1 Schwan Cosmetics Gmbh & Co. KG Heroldsberg , DE 90562 SWI-DO 53CC-02 EARTH EYELINER 02-JAN-2008 COSM COLOR CSTIC LBLG Germany 231-7408047-6 83 2 Schwan Cosmetics Gmbh & Co. KG Heroldsberg , DE 90562 SWI-DO 53CC-02 GUNMETAL EYELINER 02-JAN-2008 COSM COLOR CSTIC LBLG Italy 231-7408047-6 3 1 Intercos Spa Agrate Brianza MI, IT 200414 SWI-DO 53CD-06 LASTING TINT SEMI-PERM WATER 02-JAN-2008 COSM COLOR CSTIC LBLG Italy 231-7408047-6 21 1 Intercos Spa Agrate Brianza MI, IT 200414 SWI-DO 53CD-06 LASTING TINT SEMI-PERM WATER 02-JAN-2008 COSM COLOR CSTIC LBLG Italy 231-7408047-6 74 3 Intercos Spa Agrate Brianza MI, IT 200414 SWI-DO 53CD-06 LASTING TINT SEMI-PERM WATER 02-JAN-2008 COSM COLOR CSTIC LBLG Italy 231-7408047-6 82 2 Intercos Spa Agrate Brianza MI, IT 200414 SWI-DO 53CD-06 LASTING TINT SEMI-PERM WATER 02-JAN-2008 COSM COLOR CSTIC LBLG China WGB-7091421-0 43 1 Gateway Trading Guangzhou , CN 510406 FLA-DO 53CG-02 EYE PENCIL 18-JAN-2008 UNSAFE COL CSTIC LBLG COSMETLBLG Taiwan BTF-0012944-1 1 1 T.G.B. United Enterprise Co Tainan Hsien , TW CHI-DO 53CH-03 EYE SHADOW MAKE-UP 23-JAN-2008 UNSAFE COL India 112-7368386-4 2 1 Raun Harman Exports (P) Ltd. New Delhi , IN 110052 NOL-DO 53CH-07 857260657269 NATURAL HENNA 15-JAN-2008 UNSAFE COL Mexico BMU-0003584-6 4 1 Grisi Hnos, S.A. de C.V. Mexico, D.F. , MX SWI-DO 53EC-03 Chamomile Hair Lightener Spray 04-JAN-2008 UNSAFE COL China WGB-7091421-0 19 1 J Gateway Trading Guangzhou , CN 510406 FLA-DO 53ED-06 Herbal Product Shampoo cover color and Light (60-750ml/96-40 18-JAN-2008 CSTIC LBLG COSMETLBLG Mexico G01-0246450-3 3 3 Central Botanica del Nayar, S.A. de C.V. Ensenada MX-BCN, MX 22830 SWI-DO 53ED-99 ROSEMARY OIL F/HAIR 04-JAN-2008 UNSAFE COL Mexico BMU-0003687-7 4 1 Grisi Hnos, S.A. de C.V. Mexico, D.F. , MX SWI-DO 53FA-06 Hair Lightener, Manzanilla (Chamomile) 24-JAN-2008 UNSAFE COL Mexico BMU-0003747-9 4 1 Grisi Hnos, S.A. de C.V. Mexico, D.F. , MX SWI-DO 53FD-03 Chamomile Hair Lightener Lotion 24-JAN-2008 UNSAFE COL China EG6-1426498-4 6 1 Zhejiang Jinhua Garland Cosmetics Jinhua Zhejiang, CN 321000 NYK-DO 53GC-05 LIP GLOSS (SAME PRODUCT/MANUF AS LINE 015/001) 4 COLORS/FLAV 08-JAN-2008 UNSAFE COL China EG6-1426498-4 15 1 B Zhejiang Jinhua Garland Cosmetics Jinhua Zhejiang, CN 321000 NYK-DO 53GC-05 LIP GLOSS (SWEETS - STRAWBERRY SWIRL) FROM CHINA 08-JAN-2008 UNSAFE COL COSMETLBLG China EG6-1426498-4 15 1 D Zhejiang Jinhua Garland Cosmetics Jinhua Zhejiang, CN 321000 NYK-DO 53GC-05 LIP GLOSS (SWEETS - PEPPERMINT SWIRL) FROM CHINA 08-JAN-2008 COSM COLOR COSMETLBLG Taiwan ANP-0008903-8 4 1 B Daison Industries Co Ltd Hiroshima-Ken , JP 739-8501 SEA-DO 53GD-05 HYALURONIC ACED LIP CREAM 31-JAN-2008 CSTIC LBLG India WUG-0138677-9 16 1 Hesh Pharma Mfg & Exporter Of Herbal Products Mumbai , IN 400104 LOS-DO 53GH-99 Mehandi Powder ( ingredients: mehandi powder 100% (Lawsonia 12-JAN-2008 UNSAFE COL China WGB-7091421-0 15 1 Gateway Trading Guangzhou , CN 510406 FLA-DO 53GK-05 LIP PREPARATIONS 18-JAN-2008 UNSAFE COL CSTIC LBLG COSMETLBLG China E94-1041969-7 6 1 Global Hotel Necessities Co., Ltd. Nanhai District, Guangdong , CN 1234 CHI-DO 53IG-01 TOOTHPASTE 10-JAN-2008 UNAPPROVED United States 110-0874432-4 1 1 Sexi Smile Llc Lake Ronkonkoma, NY 11779-6524 NYK-DO 53IG-01 Teeth Whitener and Lip Gloss (2-in-1); Boardroom Berry, Bomb 16-JAN-2008 CSTIC LBLG India HA9-0700160-6 2 1 Henkel India Ltd. Chennai - 18 , IN LOS-DO 53IG-01 Neem Active Toothpaste 19-JAN-2008 HEALTH C UNAPPROVED China 112-7662338-8 7 1 Taizhou Haohai Manufacturing Corp. Taizhou, Zhejiang Provence , CN 318050 BLT-DO 53JD-01 SHOWER GEL SET 17-JAN-2008 UNSAFE COL Ghana EU7-2702266-4 3 1 nakwass enterprise Kumasi GH-NOTA, GH none SEA-DO 53JY-01 SOAP 16-JAN-2008 FILTH CSTIC LBLG Nicaragua 745-0033868-1 6 1 O Maria Elena Gutierrez Masaya , NI FLA-DO 53JY-01 Mennan - Baby Magic Soap 29-JAN-2008 CSTIC LBLG China WGB-7091421-0 19 1 B Gateway Trading Guangzhou , CN 510406 FLA-DO 53LC-03 Hand Cream 18-JAN-2008 UNSAFE COL CSTIC LBLG COSMETLBLG China WGB-7091421-0 19 1 C Gateway Trading Guangzhou , CN 510406 FLA-DO 53LC-03 Gift Sets of Creams and Lotions 18-JAN-2008 CSTIC LBLG COSMETLBLG India HA9-0700160-6 3 1 A Hindustan Lever Ltd. Mumbai Tinsukia District, IN LOS-DO 53LC-06 multiVitamin TOTAL FAIRNESS CREAM 19-JAN-2008 NOT LISTED UNAPPROVED India HA9-0700160-6 3 1 B Hindustan Lever Ltd. Mumbai Tinsukia District, IN LOS-DO 53LC-06 multiVitamin TOTAL FAIRNESS CREAM 19-JAN-2008 NOT LISTED UNAPPROVED India HA9-0700160-6 3 1 C Hindustan Lever Ltd. Mumbai Tinsukia District, IN LOS-DO 53LC-06 ayurvedic NATURAL FAIRNESS CREAM 19-JAN-2008 NOT LISTED UNAPPROVED Israel 101-7673408-4 2 1 E. L. Erman Cosmetics Mfg Ashdod , IL FLA-DO 53LC-06 MOISTURIZING CREAM NORMAL TO DRY SKIN 30-JAN-2008 NOT LISTED Italy KL1-0140028-3 1 1 Rimpex Scs Beirut , LB NYK-DO 53LC-06 BODY CREAM 31-JAN-2008 NOT LISTED UNAPPROVED France T94-0047392-0 7 1 Groupe Gm Malakoff , FR 92240 FLA-DO 53LC-99 SUN POUCH 15-JAN-2008 NOT LISTED United Kingdom 946-0603923-1 3 1 Reckitt Benkiser Ltd Swindon , GB SN57XZ LOS-DO 53LC-99 DETTOL DISINFECTATNT-LIQUID 12/9 OZ (250ML) 28-JAN-2008 NOT LISTED Germany 112-7501645-1 1 8 Labothene Pforzeheim Allemagne , DE D-75179 NOL-DO 53LD-01 861149906309 CLEANSING MILK 09-JAN-2008 CSTIC LBLG Germany 112-7501645-1 1 10 Labothene Pforzeheim Allemagne , DE D-75179 NOL-DO 53LD-01 861149906309 CLEANSING GEL 09-JAN-2008 CSTIC LBLG Mexico G01-0246450-3 4 1 Central Botanica del Nayar, S.A. de C.V. Ensenada MX-BCN, MX 22830 SWI-DO 53LD-03 DISPAN - VIT BODY CREAM 04-JAN-2008 UNSAFE COL India 399-0932028-3 3 1 Ahmed Muridi Awes Dubai , AE MIN-DO 53LD-03 RHEUMAVEDIC CREAM 24-JAN-2008 UNAPPROVED Germany 112-7501645-1 1 3 Labothene Pforzeheim Allemagne , DE D-75179 NOL-DO 53LD-06 861149906309 MOISTURIZING GEL 09-JAN-2008 CSTIC LBLG Germany 112-7501645-1 1 4 Labothene Pforzeheim Allemagne , DE D-75179 NOL-DO 53LD-06 861149906309 MOISTURIZING GEL 09-JAN-2008 COSM COLOR Germany 112-7501645-1 1 9 Labothene Pforzeheim Allemagne , DE D-75179 NOL-DO 53LD-06 861149906309 VISALIX HYDROSTABILE 09-JAN-2008 COSM COLOR Germany 112-7501645-1 1 14 Labothene Pforzeheim Allemagne , DE D-75179 NOL-DO 53LD-06 861149906309 BEAUTY CREAM 09-JAN-2008 COSM COLOR CSTIC LBLG Germany 112-7501645-1 1 15 Labothene Pforzeheim Allemagne , DE D-75179 NOL-DO 53LD-06 861149906309 BEAUTY CREAM 09-JAN-2008 COSM COLOR CSTIC LBLG Germany 112-7501645-1 1 13 Labothene Pforzeheim Allemagne , DE D-75179 NOL-DO 53LD-08 861149906309 MUDD FACE MASK 09-JAN-2008 COSMETLBLG Germany 112-7501645-1 1 5 Labothene Pforzeheim Allemagne , DE D-75179 NOL-DO 53LD-10 861149906309 MENULPHIA HYDRATANTE 09-JAN-2008 CSTIC LBLG Germany 112-7501645-1 1 6 Labothene Pforzeheim Allemagne , DE D-75179 NOL-DO 53LD-10 861149906309 MENULPHIA CREAM 09-JAN-2008 CSTIC LBLG Germany 112-7501645-1 1 2 Labothene Pforzeheim Allemagne , DE D-75179 NOL-DO 53LD-99 861149906309 SKIN SERUM 09-JAN-2008 CSTIC LBLG Germany 110-1051528-2 1 3 Labor Bio Guelichstrasseguelichstrasse , DE P-75179 NYK-DO 53MC-02 Sunblock Cream 18-JAN-2008 DIRECTIONS Germany 110-1051528-2 1 1 Labor Bio Guelichstrasseguelichstrasse , DE P-75179 NYK-DO 53MD-02 Tanning Oil Spray 18-JAN-2008 DIRECTIONS Germany 110-1051528-2 1 2 Labor Bio Guelichstrasseguelichstrasse , DE P-75179 NYK-DO 53MD-02 Sunblock Gel 18-JAN-2008 DIRECTIONS China 988-0078827-9 17 1 Long King Company East Hk , CN SEA-DO 53YC-99 TEMPORARY TATTOO 16-JAN-2008 COSMETLBLG India WUG-0138677-9 16 2 Babulal Brijbhushan Sojat City , IN LOS-DO 53YH-99 AL-AROOSA SUPERIOR QUALITY HENNA (Mtr ctn labeling: MUMTAZ H 12-JAN-2008 UNSAFE COL Kenya 112-0963454-5 1 1 Abdi Hakim Nbo , KE NOL-DO 53YY-99 926314341203/HAND & LEG CULTURAL DEC 22-JAN-2008 UNSAFE COL