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
India H77-0108828-5 19 1 Shiv Enterprises Exim Pvt Ltd Mumbai , IN NYK-DO 53BD-99 MASSAGE VICKS 15-FEB-2008 NOT LISTED Germany 112-1188824-6 1 1 Muelhens Koln , DE 50827 NOL-DO 53BD-99 610740889577-SHOWER GEL 15-FEB-2008 CSTIC LBLG France D52-8900831-5 33 1 B Young & Sweet Skin Care Paris , FR SWI-DO 53BH-01 Spa Milk Salt 28-FEB-2008 UNAPPROVED Germany 231-7408047-6 18 1 Schwan Cosmetics Gmbh & Co. KG Heroldsberg , DE 90562 SWI-DO 53CC-02 EARTH EYELINER 05-FEB-2008 COSM COLOR CSTIC LBLG China 110-3555416-2 2 1 Xiamen Royal Bath Accessories Co Xiamen City,China , CN BLT-DO 53CH-03 ITEM5973133 EYE SHADOW 19-FEB-2008 UNSAFE COL POISONOUS United Kingdom 112-1073883-0 4 2 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ NYK-DO 53CH-03 RML Color Rush Quad Chocolate 21-FEB-2008 POISONOUS United Kingdom 112-1073883-0 4 3 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ NYK-DO 53CH-03 RML Colour Rush Quad Almond 21-FEB-2008 POISONOUS United Kingdom 112-1073883-0 4 4 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ NYK-DO 53CH-03 RML Colour Rush Quad- Cafe Latte 21-FEB-2008 POISONOUS United Kingdom 112-1073883-0 4 5 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ NYK-DO 53CH-03 RML Colour Rush Quad -Bronzed 21-FEB-2008 POISONOUS United Kingdom 112-1075406-8 2 17 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ NYK-DO 53CH-03 RML Cologne Rush Duo Eye shadow 21-FEB-2008 POISONOUS United Kingdom 112-1075406-8 2 18 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ NYK-DO 53CH-03 RML Colour Rush Quad Eye shadow 21-FEB-2008 POISONOUS Germany 791-4711186-2 1 1 United Brands Marketing Gmbh Niederkassel , DE D53859 SWI-DO 53CK-02 EYELINER PEN 21-FEB-2008 POISONOUS United Kingdom 112-1075406-8 2 8 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ NYK-DO 53CK-03 RMLSS Gltr Eye Shadow Pencil-SB 21-FEB-2008 POISONOUS United Kingdom 112-1075406-8 2 9 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ NYK-DO 53CK-03 RML SS Gltr Eye Shadow Pencil-TWI 21-FEB-2008 POISONOUS United Kingdom 112-1075406-8 2 10 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ NYK-DO 53CK-03 RML SS Gltr Eye Shadow pencil SD 21-FEB-2008 POISONOUS Korea, Republic Of (South) WRE-0355495-3 4 1 Dong Sung Pharm. Co Seoul , KR 1234 LOS-DO 53CK-06 ADELIUM TRENDY MASCARA 20-FEB-2008 LABELING Korea, Republic Of (South) WRE-0355495-3 4 2 Dong Sung Pharm. Co Seoul , KR 1234 LOS-DO 53CK-06 AZN HAIR MASCARA # NATURAL BLACK 20-FEB-2008 LABELING Korea, Republic Of (South) WRE-0355495-3 4 3 Dong Sung Pharm. Co Seoul , KR 1234 LOS-DO 53CK-06 AZN HAIR MASCARA # DARK BROWN 20-FEB-2008 LABELING El Salvador AEK-9577417-6 3 1 Carmen Garcia San Salvador , SV FLA-DO 53EC-03 HAIR PREPARATION 21-FEB-2008 NO ENGLISH UNAPPROVED United Kingdom 112-1210716-6 1 1 A Intellectual Brands London , GB NW18BB NOL-DO 53EC-99 Disorder 14-FEB-2008 COSMETLBLG United Kingdom 112-1210716-6 1 1 B Intellectual Brands London , GB NW18BB NOL-DO 53EC-99 The Daddy 14-FEB-2008 COSMETLBLG United Kingdom 112-1210716-6 1 1 C Intellectual Brands London , GB NW18BB NOL-DO 53EC-99 lARGE IT 14-FEB-2008 COSMETLBLG Canada 110-1488713-3 2 1 Nisim International Brampton ON, CA L6T4M4 NYK-DO 53ED-06 NISIM DEEP CLEANSING SHAMPOO 12-FEB-2008 CSTIC LBLG India KM6-0102815-2 22 5 Veerprabhu Export House Mumbai , IN 400003 BLT-DO 53ED-07 ANOOP HAIR OIL 11-FEB-2008 CSTIC LBLG Mexico 112-0988898-4 2 1 Rafael Alvarado Col San Angel , MX NOL-DO 53ED-99 862813504777 HAIR PREPARATION 06-FEB-2008 CSTIC LBLG Canada 110-1488713-3 1 1 Nisim International Brampton ON, CA L6T4M4 NYK-DO 53ED-99 NISIM HAIR STIMULATING EXTRACT 12-FEB-2008 CSTIC LBLG United Kingdom 112-1210716-6 2 2 Intellectual Brands London , GB NW18BB NOL-DO 53ED-99 Reconstruct 14-FEB-2008 UNSAFE COL Korea, Republic Of (South) WRE-0355495-3 2 1 Dong Sung Pharm. Co Seoul , KR 1234 LOS-DO 53FD-01 HERB COLOR CREAM # 1 20-FEB-2008 LABELING Korea, Republic Of (South) WRE-0355495-3 2 2 Dong Sung Pharm. Co Seoul , KR 1234 LOS-DO 53FD-01 HERB COLOR CREAM #2 20-FEB-2008 LABELING Mexico D01-0817159-2 1 1 Cosbel Sa Mexico , MX SWI-DO 53FY-02 ROJOS VOLCANICOS 100% COLOR HAIR TINT KIT 15-FEB-2008 COLOR LBLG Korea, Republic Of (South) ANP-0009137-2 8 1 A Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO 53GD-05 Tasty Lip Cream S F M 25-FEB-2008 CSTIC LBLG Korea, Republic Of (South) ANP-0009137-2 8 1 B Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO 53GD-05 Tasty Lip Cream UV 25-FEB-2008 CSTIC LBLG United Kingdom 112-1277318-1 1 9 Organic Trevarno Helstonhelston , GB TR130 NOL-DO 53HC-03 953919410150 Organic nail conditioner 22-FEB-2008 LABELING Mexico 112-1241310-1 1 1 Nails For You Monterrey , MX NOL-DO 53HY-99 864737516024 FINISH WIPE 07-FEB-2008 COSM COLOR CSTIC LBLG Mexico 112-1241310-1 1 3 Nails For You Monterrey , MX NOL-DO 53HY-99 864737516024 NAIL LIQUID 07-FEB-2008 CSTIC LBLG Mexico 112-1241310-1 1 4 Nails For You Monterrey , MX NOL-DO 53HY-99 864737516024 ACRYLIC FINISH 07-FEB-2008 CSTIC LBLG Korea, Republic Of (South) ANP-0008906-1 6 1 Daison Industries Co Ltd Hiroshima-Ken , JP 739-8501 SEA-DO 53ID-02 MOUTH WASH 06-FEB-2008 CSTIC LBLG Thailand GL5-0833072-4 6 1 Siam Health Gropu Co., Ltd Bangkok , TH LOS-DO 53IG-01 TOOTHPASTE 06-FEB-2008 NOT LISTED Ghana AGT-0003625-2 15 1 B Samgina Enterprise Accra , GH NYK-DO 53JK-01 Hypprogel 01-FEB-2008 UNAPPROVED Brazil KM6-0105279-8 13 1 Igl Industiral Ltda Sao Paulo , BR SWI-DO 53JY-01 LUX CREAMY PERFECTION 06-FEB-2008 CSTIC LBLG COSMETLBLG COSMETLBLG Brazil KM6-0105279-8 13 2 Igl Industiral Ltda Sao Paulo , BR SWI-DO 53JY-01 LUX PEARL GLOW 06-FEB-2008 CSTIC LBLG COSMETLBLG COSMETLBLG Brazil KM6-0105279-8 13 3 Igl Industiral Ltda Sao Paulo , BR SWI-DO 53JY-01 LUX PETAL TOUCH 06-FEB-2008 CSTIC LBLG COSMETLBLG COSMETLBLG United Kingdom KM6-0105279-8 13 4 PZ CUSSONS Stockport Sk3 Oyl, GB SWI-DO 53JY-01 IMPERIAL LEATHER 06-FEB-2008 CSTIC LBLG COSMETLBLG COSMETLBLG United Kingdom 112-1277318-1 1 10 Organic Trevarno Helstonhelston , GB TR130 NOL-DO 53KD-01 953919410150.AFTERSHAVE OIL 22-FEB-2008 LABELING Spain 112-1213130-7 1 4 Cosmo Technica Srl Celra Girona , ES 17460 NOL-DO 53LC-02 935197740225 CELLUGEL 15-FEB-2008 CSTIC LBLG Ghana AGT-0003625-2 13 1 C Samgina Enterprise Accra , GH NYK-DO 53LC-03 Hyprogel 01-FEB-2008 CSTIC LBLG Ghana AGT-0003625-2 13 1 D Samgina Enterprise Accra , GH NYK-DO 53LC-03 Dermovate Cream 01-FEB-2008 UNAPPROVED Korea, Republic Of (South) AN1-0568230-4 1 4 AMORE PACIFIC CORPORATION YONGSAN-GU Kr-11, KR 140-777 LOS-DO 53LC-03 IOPE WHITE CREAM 11-FEB-2008 UNAPPROVED El Salvador AEK-9577417-6 2 1 Carmen Garcia San Salvador , SV FLA-DO 53LC-03 COFAL FORTE , CREAM 21-FEB-2008 NO ENGLISH UNAPPROVED El Salvador AEK-9577417-6 2 3 Carmen Garcia San Salvador , SV FLA-DO 53LC-03 BALSAMICO GMS, CREAM 21-FEB-2008 NO ENGLISH UNAPPROVED El Salvador AEK-9577417-6 2 4 Carmen Garcia San Salvador , SV FLA-DO 53LC-03 DERMOXIDO, FACIAL CREAM 21-FEB-2008 NO ENGLISH UNAPPROVED Israel 101-7685968-3 1 1 E. L. Erman Cosmetics Mfg Ashdod , IL FLA-DO 53LC-06 MOISTURING CREAM NORMAL TO OILY SPF-20 05-FEB-2008 NOT LISTED Israel 101-7685968-3 2 1 E. L. Erman Cosmetics Mfg Ashdod , IL FLA-DO 53LC-06 MOISTURIZING CREAM NORMAL TO DRY 05-FEB-2008 NOT LISTED Spain 112-1213130-7 1 5 Cosmo Technica Srl Celra Girona , ES 17460 NOL-DO 53LC-99 935197740225 ANTICELUTING 200ML 15-FEB-2008 UNSAFE COL CSTIC LBLG Argentina 112-0080615-9 1 2 Unknown Unknown , AR NOL-DO 53LC-99 860632671833 Natural Cream - Juniper 26-FEB-2008 CSTIC LBLG Spain 112-1213130-7 1 2 Cosmo Technica Srl Celra Girona , ES 17460 NOL-DO 53LD-01 935197740225 TONIC 15-FEB-2008 UNSAFE COL Canada 112-1135751-5 1 1 Comsetic Skin Clinic Sherwood Park ALBERTA, CA T8A4W3 NOL-DO 53LD-03 836874740320/LOTION 07-FEB-2008 FALSE Philippines 277-0117007-1 36 1 Splash Corporation Valenzuela City , PH LOS-DO 53LD-03 EXTRADERM WHITE & SMOOTH EXFOLIANT NO.1 MILD 29-FEB-2008 NOT LISTED Philippines 277-0117007-1 37 1 Splash Corporation Valenzuela City , PH LOS-DO 53LD-03 EXTRADERM WHITE & SMOOTH EXFOLIANT NO.2 MODERATE 29-FEB-2008 NOT LISTED Singapore 112-0982296-7 3 1 Syy Pte Ltd. Nee Ann , SG SAN-DO 53LD-06 861601550770 SKIN CARE WHITENER/TONER 11-FEB-2008 NOT LISTED Germany 112-1210983-2 2 1 Bayerdorf Ag Hmaburg , DE 20345 NOL-DO 53LD-06 860790241077 DNAGE Anti-Age System 13-FEB-2008 CSTIC LBLG Spain 112-1213130-7 1 1 A Cosmo Technica Srl Celra Girona , ES 17460 NOL-DO 53LD-06 Clean Milk 14-FEB-2008 UNSAFE COL Spain 112-1213130-7 1 1 B Cosmo Technica Srl Celra Girona , ES 17460 NOL-DO 53LD-06 Base Equilibrant 14-FEB-2008 CSTIC LBLG COSMETLBLG Spain 112-1213130-7 1 1 C Cosmo Technica Srl Celra Girona , ES 17460 NOL-DO 53LD-06 DERMO Mask 15-FEB-2008 UNSAFE COL Spain 112-1213130-7 1 1 D Cosmo Technica Srl Celra Girona , ES 17460 NOL-DO 53LD-06 Peeling Gomage 15-FEB-2008 CSTIC LBLG Spain 112-1213130-7 1 1 E Cosmo Technica Srl Celra Girona , ES 17460 NOL-DO 53LD-06 Balance Clear 15-FEB-2008 CSTIC LBLG COSMETLBLG Korea, Republic Of (South) WRE-0355495-3 1 1 Dong Sung Pharm. Co Seoul , KR 1234 LOS-DO 53LD-06 AC CARE T.LAB TONER 20-FEB-2008 NOT LISTED Korea, Republic Of (South) WRE-0355495-3 1 2 Dong Sung Pharm. Co Seoul , KR 1234 LOS-DO 53LD-06 AC CARE T.LAB EMULSION 20-FEB-2008 NOT LISTED Korea, Republic Of (South) WRE-0355495-3 1 3 Dong Sung Pharm. Co Seoul , KR 1234 LOS-DO 53LD-06 AC CARE T.LAB SERUM 20-FEB-2008 NOT LISTED United Kingdom MA7-0629938-9 2 1 A Serp Castelsarrasin , FR 82100 FLA-DO 53LD-06 Surcreme 26-FEB-2008 COSMETLBLG United Kingdom MA7-0629938-9 2 1 B Serp Castelsarrasin , FR 82100 FLA-DO 53LD-06 Aferligne 26-FEB-2008 COSMETLBLG COSMETLBLG El Salvador AEK-9577417-6 2 2 Carmen Garcia San Salvador , SV FLA-DO 53LD-09 CALAMINA, LOTION 21-FEB-2008 NO ENGLISH UNAPPROVED United Kingdom MA7-0629938-9 6 1 Serp Castelsarrasin , FR 82100 FLA-DO 53LD-09 TONERS 26-FEB-2008 COSM COLOR United Kingdom 112-1346887-2 1 1 Boxer Games West Yorkshire , GB NOL-DO 53LD-99 861497826710 Lovers Body Pen Sets 22-FEB-2008 UNSAFE COL United Kingdom MA7-0629938-9 1 1 B Serp Castelsarrasin , FR 82100 FLA-DO 53LD-99 Afina-Slimming Gel 26-FEB-2008 COSMETLBLG COSMETLBLG Switzerland 112-0080615-9 1 1 Ulrich Justrich AG Walzenhausen , CH 9428 NOL-DO 53LD-99 860632671833 Natural Body Care -Balsamo Balm 26-FEB-2008 CSTIC LBLG Switzerland 112-0080615-9 1 3 Ulrich Justrich AG Walzenhausen , CH 9428 NOL-DO 53LD-99 860632671833 Natural Oil - Eucasol herbal spray 26-FEB-2008 CSTIC LBLG United Kingdom 112-1277318-1 1 1 Organic Trevarno Helstonhelston , GB TR130 NOL-DO 53LY-01 953919410150.BABY CREAM 22-FEB-2008 LABELING United Kingdom 112-1277318-1 1 3 Organic Trevarno Helstonhelston , GB TR130 NOL-DO 53LY-01 953919410150.FACIAL OIL 22-FEB-2008 CSTIC LBLG LABELING United Kingdom 112-1277318-1 1 7 Organic Trevarno Helstonhelston , GB TR130 NOL-DO 53LY-01 953919410150.LIP BALM 22-FEB-2008 CSTIC LBLG LABELING United Kingdom 112-1277318-1 1 8 Organic Trevarno Helstonhelston , GB TR130 NOL-DO 53LY-01 953919410150.LIP BALM 22-FEB-2008 CSTIC LBLG COSMETLBLG United Kingdom 112-1277318-1 1 11 Organic Trevarno Helstonhelston , GB TR130 NOL-DO 53LY-01 953919410150.BABY CLEANSER 22-FEB-2008 LABELING COSMETLBLG France MA7-0629938-9 3 1 Serp Castelsarrasin , FR 82100 FLA-DO 53LY-99 Aroma Ioni Corps 26-FEB-2008 COSMETLBLG United Kingdom 112-1152169-8 1 1 All Bagged Up Latd Reading , GB RG75AN NOL-DO 53MA-99 659744943574/SPORTS SUNSCREEN 07-FEB-2008 NOT LISTED India 603-1079220-9 2 1 A Singh Mehandi Industries Sojat City , IN SEA-DO 53YC-99 Bansuri Mehandi Cone 12-FEB-2008 COSM COLOR India 603-1079220-9 2 1 B Kaveri Enterprises Delhi , IN SEA-DO 53YG-99 HENNA PASTE 12-FEB-2008 COSM COLOR India 603-1079220-9 2 1 J Singh Mehandi Industries Bangalore , IN SEA-DO 53YG-99 Singh's Dulhan, Mehandi Cone 12-FEB-2008 COSM COLOR India 603-1079220-9 2 1 C Singh Mehandi Industries Sojat City , IN SEA-DO 53YH-99 HENNA POWDER MULTIPURPOSE 12-FEB-2008 COSM COLOR India 603-1079220-9 2 1 G Kaveri Enterprises Delhi , IN SEA-DO 53YH-99 HENNA KIT 12-FEB-2008 COSM COLOR Canada 112-1199891-2 1 1 Lise Watier Cosmetiques Inc Montreal QC, CA H4T1B4 NOL-DO 53YY-99 858511376056 MAKEUP EYES 07-FEB-2008 COSMETLBLG France 112-1192745-7 1 1 Icy Beauty Forges Les , FR NOL-DO 53YY-99 947746469361 COSMETIC PREP 14-FEB-2008 CSTIC LBLG France 112-1192745-7 1 4 Icy Beauty Forges Les , FR NOL-DO 53YY-99 947746469361 ICY CONCENTRATE 14-FEB-2008 UNSAFE COL France 112-1192745-7 1 5 A Icy Beauty Forges Les , FR NOL-DO 53YY-99 Normal skin 14-FEB-2008 UNSAFE COL France 112-1192745-7 1 5 B Icy Beauty Forges Les , FR NOL-DO 53YY-99 DRY skin 14-FEB-2008 UNSAFE COL France 112-1192745-7 1 5 C Icy Beauty Forges Les , FR NOL-DO 53YY-99 FOR MEN 14-FEB-2008 UNSAFE COL France 112-1192745-7 1 6 A Icy Beauty Forges Les , FR NOL-DO 53YY-99 947746469361 QUICK LIFT 14-FEB-2008 UNSAFE COL France 112-1192745-7 1 6 B Icy Beauty Forges Les , FR NOL-DO 53YY-99 FOR MEN 14-FEB-2008 UNSAFE COL France 112-1192745-7 1 6 C Icy Beauty Forges Les , FR NOL-DO 53YY-99 Sun Effect. 14-FEB-2008 UNSAFE COL