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