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 946-0607054-1 29 1 E Britvic Soft Drinks Solihull, W Midlands , GB LOS-DO 53BD-01 RADOX STRESS RELIEF HERBAL BATH 12-MAY-2008 LACKS N/C UNAPPROVED United Kingdom 946-0607163-0 48 1 Sara Lee Household & Body Care Slough FN, GB LOS-DO 53BD-01 RADOX BUBBLE BATH 6/250ML 12-MAY-2008 CSTIC LBLG United Kingdom 946-0607163-0 66 1 Sara Lee Household & Body Care Slough FN, GB LOS-DO 53BD-01 RADOX HERBAL LIQUID SOAP 6/500ML 12-MAY-2008 COSMETLBLG HEALTH C Mexico 392-0114258-3 5 1 Probelco S.A. de D.V. Mexico, D.F. , MX 01110 SWI-DO 53CD-02 Black eyeliner display set of 12 individual bottles 16-MAY-2008 POISONOUS Mexico 392-0114258-3 4 1 Probelco S.A. de D.V. Mexico, D.F. , MX 01110 SWI-DO 53CD-06 black roll on mascara .32 oz size 14-MAY-2008 POISONOUS China MY1-0368797-5 2 1 Wai Li Far East Ltd Shantou City , CN SEA-DO 53CH-03 EYE SHADOW 01-MAY-2008 UNSAFE COL China 336-4206567-9 2 1 Sephora Beauty Canada Toronto ON, CA M5B2H1 NYK-DO 53CH-03 EYE SHADOW 08-MAY-2008 LABELING China 231-6571926-4 4 1 Great Eagle Manufacture Shenzen , CN SAN-DO 53CH-03 DISNEY FAIRIES GLITTER MAKE-UP KIT - EYE SHADOW 13-MAY-2008 UNSAFE COL China MY1-0365329-0 2 1 Top Fashion Industrial Co Ltd Shan Tou , CN SEA-DO 53CH-03 Eyeshadow (14 pc Lot 324223 GP4; 14 pc. Lot 324223 P4; 11 pc 16-MAY-2008 POISONOUS China MY1-0365329-0 2 2 Top Fashion Industrial Co Ltd Shan Tou , CN SEA-DO 53CH-03 EYESHADOW 16-MAY-2008 POISONOUS China MY1-0383389-2 2 1 Wai Li Far East Ltd Shantou City , CN SEA-DO 53CH-03 EYE MAKEUP - PLAY SET 29-MAY-2008 UNSAFE COL China 231-3891854-8 2 1 Wai Li Far East Ltd Shantou City , CN SEA-DO 53CH-03 MAKEUP TRAVEL MAKEUP SET 30-MAY-2008 COSM COLOR Canada WRT-0086680-8 1 1 Ultimate Seat Sales North York ON, CA M9L1S1 NYK-DO 53ED-99 HERBAL 7 PLUS SCALP TREATMENT 21-MAY-2008 CSTIC LBLG Canada 551-7641601-9 1 1 A Demco Manufacturing Inc Saint-hubert QC, CA J3Y2S3 NYK-DO 53GD-04 Face Paint Markers (Green) 30-MAY-2008 POISONOUS Canada 551-7641601-9 1 1 B Demco Manufacturing Inc Saint-hubert QC, CA J3Y2S3 NYK-DO 53GD-04 Face Paint Markers (Red) 30-MAY-2008 POISONOUS Canada 551-7641601-9 1 1 C Demco Manufacturing Inc Saint-hubert QC, CA J3Y2S3 NYK-DO 53GD-04 Face Paint Markers (White) 30-MAY-2008 POISONOUS Canada 551-7641601-9 1 1 D Demco Manufacturing Inc Saint-hubert QC, CA J3Y2S3 NYK-DO 53GD-04 Face Paint Markers (Blue) 30-MAY-2008 POISONOUS China BPQ-4002771-1 4 1 Guangzhou Holofun Cosmetics Fty. Guangzhou , CN LOS-DO 53GK-99 5 GLITTER STICKS W/TRAY 20-MAY-2008 UNSAFE COL CSTIC LBLG China 654-0029214-3 1 2 Shanghai Paristy Daily Chemical Co. Shanghai , CN LOS-DO 53GY-09 OASIS SHADOW & LINER QUAD 22-MAY-2008 POISONOUS China 267-5136339-6 6 1 Zhejiang Sanyuan Tourist Prod Haining City , CN 314422 SEA-DO 53ID-02 MOUTHWASH 16-MAY-2008 CSTIC LBLG United Kingdom 112-0424587-5 4 1 Pfizer Ltd Tadworth , GB NOL-DO 53ID-02 860755876569 LISTERINE 28-MAY-2008 LIST INGRE United Kingdom 946-0607162-2 151 1 Sara Lee Household & Body Care Slough FN, GB LOS-DO 53JD-01 RADOX HERBAL BATH 500ML (TIME OUT, MOISTURE SOAK, SLEEP EASY 12-MAY-2008 LACKS N/C UNAPPROVED Thailand WDA-0019585-4 23 1 Thai Supun Foods Import & Export Co Bangkok , TH LOS-DO 53JY-01 HERBAL TAMARIND SOAP 16-MAY-2008 NOT LISTED UNAPPROVED Mexico UPS-0814872-6 1 1 E Mariana Flores Zapopanzapopan , MX 45177 CIN-DO 53LB-99 Retilinien Cosmetic 09-MAY-2008 CSTIC LBLG Korea, Republic Of (South) AN1-0569065-3 1 38 AMORE PACIFIC CORPORATION YONGSAN-GU Kr-11, KR 140-777 LOS-DO 53LC-03 SULHWASOO SNOWISE CREAM 16-MAY-2008 NOT LISTED CSTIC LBLG United States MH7-4011421-9 1 1 A Intercos Italia S.P.A Milano , IT LOS-DO 53LC-03 STILA SUN SPF 15 SHADE 02-INTERNATIONAL 19-MAY-2008 NOT LISTED United States MH7-4011421-9 1 1 B Intercos Italia S.P.A Milano , IT LOS-DO 53LC-03 IPF REFEIT SPF 12-WATTS 19-MAY-2008 NOT LISTED China JN4-0053139-6 1 8 C Super Growth (Tianjin) Cosmetic Co., Ltd. Tianjin , CN LOS-DO 53LC-03 Bio Gold Crystal Anti Wrinkle Cream 19-MAY-2008 CSTIC LBLG China JN4-0053139-6 1 8 E Super Growth (Tianjin) Cosmetic Co., Ltd. Tianjin , CN LOS-DO 53LC-03 Bio Gold Crystal Double Active Cream 19-MAY-2008 CSTIC LBLG LABELING China JN4-0053139-6 1 8 D Super Growth (Tianjin) Cosmetic Co., Ltd. Tianjin , CN LOS-DO 53LC-03 Bio Gold Crystal Pearl Cream 19-MAY-2008 CSTIC LBLG LABELING China JN4-0053139-6 1 6 Super Growth (Tianjin) Cosmetic Co., Ltd. Tianjin , CN LOS-DO 53LC-03 BIO-GOLD & CRYSTAL DOUBLE ACTIVE ESSENCE CREAM 19-MAY-2008 CSTIC LBLG LABELING China JN4-0053139-6 1 3 Super Growth (Tianjin) Cosmetic Co., Ltd. Tianjin , CN LOS-DO 53LC-03 BIO-GOLD & CRYSTAL PEARL CREAM 19-MAY-2008 CSTIC LBLG LABELING China JN4-0053139-6 1 1 Super Growth (Tianjin) Cosmetic Co., Ltd. Tianjin , CN LOS-DO 53LC-03 VINTAGE WINE WHITENING FIRMING 19-MAY-2008 CSTIC LBLG LABELING Spain BXM-0001442-2 46 1 Casmara Cosmetics Sa Alaquas(Valencia) , ES 46970 SWI-DO 53LC-06 RGENERIN ENZYME - 50ML 19-MAY-2008 UNAPPROVED Spain BXM-0001442-2 52 1 Casmara Cosmetics Sa Alaquas(Valencia) , ES 46970 SWI-DO 53LC-06 CASMARA FOR LEGS CREAM - 250ML 19-MAY-2008 UNAPPROVED Peru AEK-9580278-7 3 1 Ufn Unifarm Lima , PE FLA-DO 53LC-06 SNAIL FACE CREAM 22-MAY-2008 LABELING Australia 820-0574443-6 1 1 First Lady Mississaugamississauga ONTARIO, CA L4W5E1 FLA-DO 53LC-08 ZIT ZAPPER 23-MAY-2008 NOT LISTED China JN4-0053139-6 1 7 Super Growth (Tianjin) Cosmetic Co., Ltd. Tianjin , CN LOS-DO 53LC-10 BIO-GOLD & CRYSTAL ANTI-WRINKLE CREAM 19-MAY-2008 CSTIC LBLG LABELING United Kingdom 946-0607163-0 64 1 Reckitt Benkiser Ltd Swindon , GB SN57XZ LOS-DO 53LC-99 DETTOL DISINFECTANT - LIQUID 12/9 OZ (250ML) 12-MAY-2008 NOT LISTED UNAPPROVED China 112-2346746-8 1 1 Synchrontec Cosmetics Co., Ltd, Jiangsu , CN SEA-DO 53LD-01 8636-5649-7124 Collagen Cleanser Lotion 15-MAY-2008 CSTIC LBLG Canada 112-2346065-3 5 1 Phcp Mississauga ON, CA L5T1Y9 NYK-DO 53LD-03 50ML MASSAGE OIL (M) 09-MAY-2008 COSMETLBLG Canada 112-2346065-3 8 1 Phcp Mississauga ON, CA L5T1Y9 NYK-DO 53LD-03 50ML MASSAGE OIL (M) 09-MAY-2008 COSMETLBLG Canada 112-2346065-3 11 1 Phcp Mississauga ON, CA L5T1Y9 NYK-DO 53LD-03 50ML MASSAGE OIL (M) 09-MAY-2008 COSMETLBLG Canada 112-2346065-3 17 1 Phcp Mississauga ON, CA L5T1Y9 NYK-DO 53LD-03 50ML MASSAGE OIL (M) 09-MAY-2008 COSMETLBLG Canada 112-2346065-3 20 1 Phcp Mississauga ON, CA L5T1Y9 NYK-DO 53LD-03 50ML MASSAGE OIL (M) 09-MAY-2008 COSMETLBLG Canada 112-2346065-3 23 1 Phcp Mississauga ON, CA L5T1Y9 NYK-DO 53LD-03 50ML MASSAGE OIL (M) 09-MAY-2008 COSMETLBLG Canada 112-2346065-3 26 1 Phcp Mississauga ON, CA L5T1Y9 NYK-DO 53LD-03 50ML MASSAGE OIL (M) 09-MAY-2008 COSMETLBLG Canada 112-2346065-3 29 1 Phcp Mississauga ON, CA L5T1Y9 NYK-DO 53LD-03 50ML MASSAGE OIL (M) 09-MAY-2008 COSMETLBLG Canada 112-2346065-3 29 2 Phcp Mississauga ON, CA L5T1Y9 NYK-DO 53LD-03 50ML MASSAGE OIL (M) 09-MAY-2008 COSMETLBLG Canada 112-2346065-3 32 1 Phcp Mississauga ON, CA L5T1Y9 NYK-DO 53LD-03 50ML MASSAGE OIL (M) 09-MAY-2008 COSMETLBLG Canada 112-2346065-3 35 1 Phcp Mississauga ON, CA L5T1Y9 NYK-DO 53LD-03 50ML MASSAGE OIL (M) 09-MAY-2008 COSMETLBLG Canada 112-2346065-3 38 1 Phcp Mississauga ON, CA L5T1Y9 NYK-DO 53LD-03 50ML MASSAGE OIL (M) 09-MAY-2008 COSMETLBLG Canada 112-2346065-3 41 1 Phcp Mississauga ON, CA L5T1Y9 NYK-DO 53LD-03 50ML MASSAGE OIL (M) 09-MAY-2008 COSMETLBLG Canada 112-2346065-3 44 1 Phcp Mississauga ON, CA L5T1Y9 NYK-DO 53LD-03 50ML MASSAGE OIL (M) 09-MAY-2008 COSMETLBLG Canada 112-2346065-3 49 1 Phcp Mississauga ON, CA L5T1Y9 NYK-DO 53LD-03 50ML MASSAGE OIL (M) 09-MAY-2008 COSMETLBLG Canada 112-2346065-3 2 1 Phcp Mississauga ON, CA L5T1Y9 NYK-DO 53LD-03 50ML MASSAGE OIL (M) 09-MAY-2008 COSMETLBLG Canada 112-2346065-3 14 1 Phcp Mississauga ON, CA L5T1Y9 NYK-DO 53LD-03 50ML MASSAGE OIL (M) 09-MAY-2008 COSMETLBLG Korea, Republic Of (South) AN1-0569065-3 1 40 AMORE PACIFIC CORPORATION YONGSAN-GU Kr-11, KR 140-777 LOS-DO 53LD-03 SULHWASOO SNOWISE CREAM 16-MAY-2008 NOT LISTED China EL6-0022909-9 13 1 Guangzhou Jinyimei Guangzhou , CN 510095 LOS-DO 53LD-03 BODY BEAUTY MILK 26-MAY-2008 REGISTERED China JN4-0053139-6 1 2 Super Growth (Tianjin) Cosmetic Co., Ltd. Tianjin , CN LOS-DO 53LF-03 BREAST BEAUTIFYING PADS 19-MAY-2008 CSTIC LBLG LABELING Kenya 112-0349759-2 1 1 Aman Mohd Mombasa , KE NOL-DO 53PY-99 857387495105 HAIR/LEG/HAND CULTURAL 27-MAY-2008 UNSAFE COL China 231-6571926-4 7 1 Great Eagle Manufacture Shenzen , CN SAN-DO 53YC-03 DISNEY FAIRIES GLITTER MAKE-UP KIT - SPONGE APPLICATOR 13-MAY-2008 UNSAFE COL