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
Canada 336-4686766-6 1 1
Delon Laboratories
Dollard-Des-Ormeaux QC, CA H9B2N4 NYK-DO
53AD-01 BABY SHAMPOO
02-OCT-2007 POISONOUS
Canada 336-4686766-6 2 1
Delon Laboratories
Dollard-Des-Ormeaux QC, CA H9B2N4 NYK-DO
53AD-01 BABY WASH
02-OCT-2007 POISONOUS
France 112-8101731-1 2 1
Je International S
Caussols , FR 06460 NOL-DO
53AD-02 723182693084/ROSEMARY CINEOLE
18-OCT-2007 LABELING
India 101-7523376-5 4 1
Ashiwin Fine Chemical & Pharmaceutical
Kashi Mira , IN SWI-DO
53BD-01 OIL (KALONJI-ONION)
09-OCT-2007 NOT LISTED
India J10-2701439-5 1 1 A
First August Services Pvt Limited
New Delhi , IN SWI-DO
53BD-01 Juniper Berry Oil
10-OCT-2007 UNAPPROVED
Pakistan DZ1-0345911-8 3 1 B
Mughal Magnate Intl (Pvt) Ltd
Karachi , PK SEA-DO
53BH-01 Mud masks
30-OCT-2007 CSTIC LBLG
Taiwan 231-7003152-3 1 2
Boya Enterprise Co Ltd
Ta Li City , TW NYK-DO
53CD-02 TOPAZ CRUSH JEWEL E/L
22-OCT-2007 UNSAFE COL
Taiwan 231-7003152-3 1 3
Boya Enterprise Co Ltd
Ta Li City , TW NYK-DO
53CD-02 JWL E/L QUARTZ
22-OCT-2007 UNSAFE COL
Saudi Arabia E22-0058991-0 11 5 A
Ayn & Getti P. Ltd.
Bombay , IN SEA-DO
53CD-02 Kohl Aswad
31-OCT-2007 COSM COLOR
COLOR LBLG
Saudi Arabia E22-0058991-0 11 5 B
Rani
Riyadh , SA SEA-DO
53CD-02 Kajal/Kohl
31-OCT-2007 COSM COLOR
COLOR LBLG
United Kingdom T77-1027539-9 10 1
Coty Manufacturing UK Ltd.
Ashford Kent, GB TN25 4AQ BLT-DO
53CH-03 EYE SHADOW (EYE MAKEUP PREPARATIONS);POWDER;
23-OCT-2007 POISONOUS
Germany 791-4379274-9 1 1
United Brands Marketing Gmbh
Niederkassel , DE D53859 SWI-DO
53CK-02 EYE, LIP LINER
26-OCT-2007 POISONOUS
India 101-7553533-4 28 1
Aero Pharma (Silvassa)
Silvassa , IN 396230 SWI-DO
53CK-06 MAKEUP (KAJAL)
10-OCT-2007 UNSAFE COL
FALSE
COSMETLBLG
Taiwan 112-8026893-1 1 1
Ying Piao (Eagle) Industrial Co., Ltd.
Nanton , TW SAN-DO
53CY-02 850671903352EYELINER PENCIL
29-OCT-2007 UNSAFE COL
United Kingdom 110-0346745-9 2 1
Stargazer
Croydoncroydon , GB CR00 CIN-DO
53CY-99 EYE MAKEUP: MASCARA,EYESHADOW,EYELINER
22-OCT-2007 COSM COLOR
Dominican Republic M21-0736380-8 2 1
Laboratorios Key C Por A
Santo Domingo , DO FLA-DO
53EC-01 HAIR CONDITIONER
18-OCT-2007 UNSAFE COL
India 561-0084115-6 4 1 B
K.C. Pandey & Sons
Vrindavan , IN FLA-DO
53EC-01 PANDEY HERBAL OILS
31-OCT-2007 CSTIC LBLG
India 561-0084115-6 4 1 C
Shree Hanuman Ayurvedic Rasayan Shala
Loni Ghaziabad IN-UP, IN 201102 FLA-DO
53EC-01 TARA HEALING INCENSE
31-OCT-2007 CSTIC LBLG
Dominican Republic KK1-0000854-3 11 1 A
Alopecil Corporation C X A
Santo Domingo , DO FLA-DO
53EC-07 APRETADORA - Fortifying Capillar Treatment with Apretol - 15
29-OCT-2007 COSMETLBLG
India DY2-0707022-7 2 28
Dey'S Medical Stores Pvt. Ltd.
Kolkata , IN 700087 SWI-DO
53ED-01 "Keo Karpin Hair Oil" (200 ml)
09-OCT-2007 UNSAFE COL
LABELING
India AYG-1001215-6 62 1
Unique Fragrances
Delhi D, IN 110034 SAN-DO
53ED-99 HESH CASTOR HAIR OIL
11-OCT-2007 UNSAFE COL
Canada M76-6091341-0 29 1
Assured Packaging Inc.
Mississauga ON, CA L5T2V4 NYK-DO
53FA-05 Color Hairspray
24-OCT-2007 CSTIC LBLG
Saudi Arabia E22-0058991-0 11 5 E
pradhan herbal company
Bangalore IN-KA, IN 5600 76 SEA-DO
53FG-02 Pure Henna (Eaceles Brown)
31-OCT-2007 COSM COLOR
CSTIC LBLG
India 101-7553533-4 5 1
pearls of beauty
New Delhi , IN SWI-DO
53FG-04 Henna Hair, hand and foot dye
10-OCT-2007 UNSAFE COL
LABELING
COSMETLBLG
India UT4-0071014-1 18 1
Unique Fragrances
Delhi D, IN 110034 SAN-DO
53FH-01 HESH BRAHANI AMLA HAIR OIL (HAIR CARE PRODUCT)
23-OCT-2007 UNSAFE COL
COSMETLBLG
India UT4-0071014-1 23 1
Unique Fragrances
Delhi D, IN 110034 SAN-DO
53FH-01 KEO KARPIN HAIR OIL
23-OCT-2007 UNSAFE COL
COSMETLBLG
India UT4-0071014-1 23 2
Unique Fragrances
Delhi D, IN 110034 SAN-DO
53FH-01 KEO KARPIN HAIR OIL
23-OCT-2007 UNSAFE COL
COSMETLBLG
France JN4-0050625-7 1 8
Shuyis
Paris , FR 75012 LOS-DO
53GC-03 BEAUTY FOUNDATION CREAM
23-OCT-2007 NOT LISTED
France JN4-0050625-7 1 3
Shuyis
Paris , FR 75012 LOS-DO
53GD-03 MULT ACTIVE TINTED CREAM
23-OCT-2007 NOT LISTED
Canada 551-6969166-9 1 1
Demco Manufacturing Inc
Saint-hubert Quebec, CA J3Y2S3 NYK-DO
53GD-04 Face Paint (Various) 14mL
02-OCT-2007 POISONOUS
China DE6-1255601-4 22 1
Arbor Toys Company Limited
Kowloon (East) , HK NYK-DO
53GD-05 Disney Princess Lip Gloss Rings
17-OCT-2007 UNSAFE COL
COSMETLBLG
United Kingdom 112-8152779-8 1 1 A
Nhp Ltd
Hants , GB NOL-DO
53GD-99 Iten # 1 Calosol G4 C-Gel
01-OCT-2007 LABELING
United Kingdom 112-8152779-8 1 1 B
Nhp Ltd
Hants , GB NOL-DO
53GD-99 Iten # 2 Calosol 4H Recovery Ointment
01-OCT-2007 CSTIC LBLG
LABELING
United Kingdom 110-0346745-9 4 1
Stargazer
Croydoncroydon , GB CR00 CIN-DO
53GD-99 LIPGLOSS
22-OCT-2007 COSM COLOR
Saudi Arabia E22-0058991-0 11 5 C
Saleh Ahmed Bin Afif Cosmetics Factory
Unknown , SA SEA-DO
53GG-03 Kone Henna Paste
31-OCT-2007 COSM COLOR
CSTIC LBLG
Saudi Arabia E22-0058991-0 11 5 D
Saleh Ahmed Bin Afif Cosmetics Factory
Unknown , SA SEA-DO
53GG-03 Nail Henna
31-OCT-2007 COSM COLOR
CSTIC LBLG
United Kingdom 110-0346745-9 3 1
Stargazer
Croydoncroydon , GB CR00 CIN-DO
53GH-02 POWDER
22-OCT-2007 COSM COLOR
China 442-1996239-4 9 1 B
Ming Fai Plastic Industrial Co
Shenzhen , CN LOS-DO
53GI-99 Hydrating circulation cream
31-OCT-2007 NOT LISTED
Thailand 417-0244125-8 10 1
Colgate Palmolive (Thailand) Co.,Ltd.
Kongtoy , TH NYK-DO
53IC-01 TOOTHPASTE
09-OCT-2007 LABELING
India K80-0942570-4 11 1
P. J. Exports
Kalher Village In-Mh, IN 421302 SAN-DO
53ID-02 MOUTH FRESHNER
22-OCT-2007 FILTH
India KM6-0032617-7 5 1
TIT-BIT
MUMBAI , IN NYK-DO
53IH-02 MIX MUKHWAS
18-OCT-2007 UNSAFE COL
Taiwan ES2-0093087-4 1 1
Hao Tian Shing Bioengineering Research and Development Co.,
Tahsi Town TW-TAO, TW 000335 LOS-DO
53IH-99 BRUSHING TEETH POWDER
22-OCT-2007 CSTIC LBLG
China BWJ-0034916-1 1 1
Shanghai Triplan International
Shanghai , CN LOS-DO
53IY-99 TEETH WHITENING SYSTEMS
23-OCT-2007 NO 510(K)
UNAPPROVED
Poland 429-0771224-6 1 15
Dax Cosmetics Sp.Zo.O
Wiazowna , PL SEA-DO
53JC-01 PERFECTA NO PROBLEM CLEANSING MILK
22-OCT-2007 COSM COLOR
CSTIC LBLG
Dominican Republic KK1-0000854-3 11 1 C
Alopecil Corporation C X A
Santo Domingo , DO FLA-DO
53JD-03 HIGISOL - For Intimate Higiene / Strong anti-bacterial solut
29-OCT-2007 CSTIC LBLG
Dominican Republic KK1-0000854-3 11 1 B
Alopecil Corporation C X A
Santo Domingo , DO FLA-DO
53JD-99 HIGISOL GEL - Liquid Soap Germicide Sour and Mentholated Int
29-OCT-2007 COSM COLOR
China 442-1996239-4 1 4
Ming Fai Plastic Industrial Co
Shenzhen , CN LOS-DO
53JF-99 REFRESHING HAND FACE TOWELETTE 7X7"
31-OCT-2007 NOT LISTED
FALSE
China 442-1996239-4 1 5
Ming Fai Plastic Industrial Co
Shenzhen , CN LOS-DO
53JF-99 REFRESHING HAND AND FACE TOWELETTE 7X7"
31-OCT-2007 NOT LISTED
FALSE
Mexico D01-0815803-7 1 2
Unilever de Mexico S.A. de C.V.
Cuernevaca, Morelos , MX 62500 SWI-DO
53JI-02 STEFANO BARRA
30-OCT-2007 CSTIC LBLG
Spain BOY-0000422-3 1 3
Jabones Pardo
Madrid , ES 28946 FLA-DO
53JK-01 SOAP FOR SKIN
23-OCT-2007 UNSAFE COL
NOT LISTED
UNAPPROVED
India 101-7523376-5 1 2 C
Hindustan Lever House Ltd
Mumbai , IN 1234 SWI-DO
53JY-01 Pears Blue Soap
09-OCT-2007 NOT LISTED
Thailand 112-8137575-0 2 1
Hada Enterprise Co
Bangkok , TH SEA-DO
53JY-01 861294098870 BODY SOAPS
16-OCT-2007 CSTIC LBLG
Germany 112-8462435-2 1 1
Molecular Cosmetics Gmbh
Dusseldorf , DE 40212 NOL-DO
53LC-01 860635358080.FACE CREA M
12-OCT-2007 CSTIC LBLG
COSMETLBLG
Thailand 112-8137575-0 1 1
Hada Enterprise Co
Bangkok , TH SEA-DO
53LC-01 861294098870 FACIAL CREAM & SCRUB
16-OCT-2007 CSTIC LBLG
China 804-6685980-0 1 1
New Beauty Fashion Factory 4th Fl, 20 Alley Dap
Guangzhou , CN LOS-DO
53LC-02 BEAUTY MASTER/DEPILATORIES
17-OCT-2007 DIRECTIONS
REGISTERED
NO 510(K)
France BNW-9718555-8 3 1
Parbel Of Florida, Inc.
Miami, FL 33126-7002 FLA-DO
53LC-03 SKIN CARE CREAM.
05-OCT-2007 UNAPPROVED
Mexico D01-0815803-7 2 1
Distribuidora E.G.M.
Tijuana Baja California, MX SWI-DO
53LC-03 Concha Nacar mother Pearl cream
30-OCT-2007 UNAPPROVED
Saudi Arabia E22-0058991-0 11 2 A
Diana De Beaute s.a.l.
Beirut , LB SEA-DO
53LC-03 Creme C.T.R. Diana
31-OCT-2007 UNAPPROVED
Saudi Arabia E22-0058991-0 11 2 B
Unknown
Unknown , LB SEA-DO
53LC-03 Rose Cream
31-OCT-2007 UNAPPROVED
Saudi Arabia E22-0058991-0 11 6 A
Joy Creators
Calcutta , IN 700072 SEA-DO
53LC-03 Roses Fairness & Vanishing Cream With Vitamin E & Sunscreen
31-OCT-2007 UNAPPROVED
Saudi Arabia E22-0058991-0 11 7 A
Joy Creators
Calcutta , IN 700072 SEA-DO
53LC-03 Skin Fruits Anti-Wrinkle Massage Cream
31-OCT-2007 UNAPPROVED
Pakistan DB7-2022033-6 1 1
Rani &Company
Karachi , PK ATL-DO
53LC-99 BODY CREAM
11-OCT-2007 UNSAFE COL
France 112-8599584-3 1 1
St. Dalfour Freres
Cedex , FR 4004 NOL-DO
53LC-99 942532852856 WHITENING CREAM
19-OCT-2007 CSTIC LBLG
LABELING
COSMETLBLG
France BRL-0007666-7 1 1
P & N International Company Ltd
Mauguio , FR 34130 LOS-DO
53LC-99 SLIMMING SKIN CREAM I
23-OCT-2007 CSTIC LBLG
France BRL-0007666-7 1 4
P & N International Company Ltd
Mauguio , FR 34130 LOS-DO
53LC-99 SLIMMING SKIN CREAM IV
23-OCT-2007 CSTIC LBLG
France BRL-0007666-7 1 3
P & N International Company Ltd
Mauguio , FR 34130 LOS-DO
53LC-99 SLIMMING SKIN CREAM III
23-OCT-2007 CSTIC LBLG
France BRL-0007666-7 1 2
P & N International Company Ltd
Mauguio , FR 34130 LOS-DO
53LC-99 SLIMMING SKIN CREAM II
23-OCT-2007 CSTIC LBLG
Spain BOY-0000422-3 1 1
Jabones Pardo
Madrid , ES 28946 FLA-DO
53LD-01 LOTIONS FOR SKIN
23-OCT-2007 UNSAFE COL
NOT LISTED
WARNINGS
UNAPPROVED
Peru NL7-0104484-3 1 1 A
natural products international s.a.c.
san miguel PE-LIM, PE 150136 FLA-DO
53LD-03 BODY GEL
25-OCT-2007 CSTIC LBLG
Peru NL7-0104484-3 1 1 B
natural products international s.a.c.
san miguel PE-LIM, PE 150136 FLA-DO
53LD-03 BODY GEL (anticelulitico)
25-OCT-2007 UNSAFE COL
CSTIC LBLG
China 442-1996239-4 10 1
Ming Fai Plastic Industrial Co
Shenzhen , CN LOS-DO
53LD-03 TEMPLE RUB 5ML TEMPLE RUB FILLED INTO CA-12 POT W/4 CMYK COL
31-OCT-2007 NOT LISTED
FALSE
China 442-1996239-4 10 2
Ming Fai Plastic Industrial Co
Shenzhen , CN LOS-DO
53LD-03 TEMPLE RUB 5ML TEMPLE RUB FILLED INTO CA-12 POT W/4 CMYK COL
31-OCT-2007 NOT LISTED
FALSE
France 112-8254366-1 1 1
Orgev Laboratoires
Rambouillet , FR 78120 NOL-DO
53LD-06 862506876330/SERUM
03-OCT-2007 CSTIC LBLG
COSMETLBLG
United States BDN-0017582-3 1 1
Elizabeth Halen Corp.
Los Angeles, CA 90010 LOS-DO
53LD-06 DERMALOGIC HYDROSILK SERUM
22-OCT-2007 CSTIC LBLG
United Kingdom 112-8619974-2 1 4
Nougat London Ltd
London , GB 21T3LW NOL-DO
53LD-06 949511013474 BODY BUTTER
23-OCT-2007 COSMETLBLG
Brazil AZW-0037518-2 5 1
Unilever De Argentina
Buenos Aires , AR 1427 FLA-DO
53LH-04 FOOT POWDER
30-OCT-2007 CSTIC LBLG
India DY2-0708034-1 1 1
Cholayil Pharmaceuticals P Ltd
Banglore , IN 561203 SWI-DO
53LY-99 MEDIMAX BAR SOAP
18-OCT-2007 NOT LISTED
Germany 112-8600787-9 1 1
Rosenpark Klinik
Darmstadt , DE 64285 NOL-DO
53MD-99 857073718486/SUNSCREEN LOTION/50ML
23-OCT-2007 NOT LISTED
LACKS N/C
NO ENGLISH
China 344-0746074-9 1 1
Changzhou Medical Raw Material Factory
Jiangsu , CN PHI-DO
53PH-99 PROGESTERONE TO BE USED IN HERBAL HARMONIZING COSMETIC CREAM
18-OCT-2007 DIRECTIONS
India 112-8502906-4 1 2
Pentavox International
Ludhiana IN-PB, IN 141001 NOL-DO
53PY-99 857454943639 SESAME MASSAGE OILS
16-OCT-2007 CSTIC LBLG
France 112-8101731-1 1 2
Je International S
Caussols , FR 06460 NOL-DO
53YC-99 723182693084/BASE CREAM
18-OCT-2007 LABELING
Canada M76-6091341-0 35 1
Demco Manufacturing Inc
Saint-hubert Quebec, CA J3Y2S3 NYK-DO
53YK-99 Face Paint Markers
24-OCT-2007 COSM COLOR
POISONOUS
India DY2-0708034-1 1 5
Babulal Brijbhushan
Soja , IN SWI-DO
53YY-99 SUPERIOR QUALITY HENNA
18-OCT-2007 COSM COLOR
Germany 112-8695666-1 1 1
Logitrans Gmbh
Kalchreuth , DE 90562 NOL-DO
53YY-99 946595489933 COSMETIC PENCIL
30-OCT-2007 CSTIC LBLG
COSMETLBLG