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