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