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