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 DZ1-0352892-0 1 2 Hsahnaz Herbals New Delhi , IN SAN-DO 53AC-02 FLOWER POWER AYRURVEDIC REHYDRANT TREATMENT LOTION (NFMU) 24-AUG-2007 CSTIC LBLG India DZ1-0352892-0 2 6 Hsahnaz Herbals New Delhi , IN SAN-DO 53AC-02 SHARSOSE (200ML) CREAM (NOT FOR MEDICAL USE) 24-AUG-2007 UNSAFE COL India DZ1-0352892-0 2 7 Hsahnaz Herbals New Delhi , IN SAN-DO 53AC-02 SHARSOSE ( 15ML) LOTION (NOT FOR MEDICAL USE) 24-AUG-2007 UNSAFE COL China EG6-1354123-4 2 1 Xiamen Winstar Corp Xiamenxiamen , CN 361000 NYK-DO 53BH-01 Ice Cream Bath Bombs 16-AUG-2007 UNSAFE COL LABELING COSMETLBLG Italy 112-7396897-6 1 8 Agami Srl Roma , IT 50175 NOL-DO 53CC-05 860454310946 BEAUTY EYE 30-AUG-2007 UNSAFE COL United Kingdom 112-5958239-5 10 2 Hive Beauty Tamworth , GB NOL-DO 53CD-05 904376761184 CLEANER 01-AUG-2007 CSTIC LBLG Belgium 112-5958239-5 9 1 Hive Of Beauty Europe Bvba Temse , BE NOL-DO 53CD-05 904376761184 CLEANER 01-AUG-2007 CSTIC LBLG United Kingdom T77-1021237-6 14 1 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ BLT-DO 53CH-03 EYE SHADOW (EYE MAKEUP PREPARATIONS);POWDER; 06-AUG-2007 HELD INSAN United Kingdom T77-1024447-8 1 1 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ NYK-DO 53CH-03 EYE SHADOW (EYE MAKEUP PREPARATIONS);POWDER; 24-AUG-2007 FILTH HELD INSAN United Kingdom T77-1024447-8 2 1 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ NYK-DO 53CH-03 EYE SHADOW (EYE MAKEUP PREPARATIONS);POWDER; 24-AUG-2007 FILTH HELD INSAN United Kingdom T77-1024447-8 3 1 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ NYK-DO 53CH-03 EYE SHADOW (EYE MAKEUP PREPARATIONS);POWDER; 24-AUG-2007 FILTH HELD INSAN United Kingdom T77-1024447-8 4 1 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ NYK-DO 53CH-03 EYE SHADOW (EYE MAKEUP PREPARATIONS);POWDER; 24-AUG-2007 FILTH HELD INSAN United Kingdom T77-1024447-8 5 1 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ NYK-DO 53CH-03 EYE SHADOW (EYE MAKEUP PREPARATIONS);POWDER; 24-AUG-2007 FILTH HELD INSAN Germany 267-5111436-9 1 1 Unknown Unknown , DE DET-DO 53CK-02 EYE LINER 22-AUG-2007 COSM COLOR CSTIC LBLG COSMETLBLG United Arab Emirates 110-8681827-9 6 1 Highlight Airfreig Dubai , AE CIN-DO 53DA-02 PERFUME 13-AUG-2007 CSTIC LBLG Nigeria J11-0040553-6 7 1 B Adefolorunsho Tech. Ent. Ogun State , NG SWI-DO 53EC-01 Hair Fertilizer 30-AUG-2007 NOT LISTED Saudi Arabia 112-7653721-6 1 1 Al Enaya Book Store Jeddah , SA NOL-DO 53EC-99 857385951015 HAIR CREAM 24-AUG-2007 CSTIC LBLG COSMETLBLG Spain 112-5348190-9 1 1 L'Oreal Barcolona , ES NOL-DO 53ED-01 856058184430 CONDITIONER 18-AUG-2007 CSTIC LBLG Spain 112-5348190-9 1 2 L'Oreal Barcolona , ES NOL-DO 53ED-01 856058184430 CONDITIONER 18-AUG-2007 CSTIC LBLG France 112-5348190-9 3 1 Loreal Clichy Cedex , FR 92117 NOL-DO 53ED-01 856058184430 CONDITIONER 18-AUG-2007 CSTIC LBLG LABELING Dominican Republic WX8-4913417-5 1 4 Laboratorios Key C Por A Santo Domingo , DO SJN-DO 53ED-06 SHAMPOO 10 IN 1 08-AUG-2007 COSM COLOR Spain 508-0302345-1 7 1 Cristian Lay S.A. Badajoz, Espana , ES SJN-DO 53ED-06 SHAMPOOS 09-AUG-2007 UNAPPROVED Spain 508-0302220-6 7 1 B Cristian Lay S.A. Badajoz, Espana , ES SJN-DO 53ED-06 hair loss control shampoo 09-AUG-2007 UNAPPROVED Spain 508-0302220-6 7 1 C Cristian Lay S.A. Badajoz, Espana , ES SJN-DO 53ED-06 anti-dandruff shampoo 09-AUG-2007 NOT LISTED INCONSPICU UNAPPROVED Spain 508-0302556-3 7 1 A Cristian Lay S.A. Badajoz, Espana , ES SJN-DO 53ED-06 Hair Loss Control Shampoo 10-AUG-2007 UNAPPROVED Mexico D01-0815151-1 1 7 Unilever de Mexico S.A. de C.V. Cuernevaca, Morelos , MX 62500 SWI-DO 53ED-06 Sedal Ondas Irresistibles Shampoo 13-AUG-2007 CSTIC LBLG Mexico D01-0815203-0 2 1 Unilever de Mexico S.A. de C.V. Cuernevaca, Morelos , MX 62500 SWI-DO 53ED-06 Sedal Shampoo "Liso Perfecto" 13-AUG-2007 CSTIC LBLG Mexico D01-0815203-0 2 2 Unilever de Mexico S.A. de C.V. Cuernevaca, Morelos , MX 62500 SWI-DO 53ED-06 Sedal Shampoo "Rizos Obedientes" 13-AUG-2007 CSTIC LBLG Mexico D01-0815204-8 3 2 Unilever de Mexico S.A. de C.V. Cuernevaca, Morelos , MX 62500 SWI-DO 53ED-06 Sedal Shampoo "Ondas Irresistibles" 13-AUG-2007 CSTIC LBLG France 112-5348190-9 2 1 Loreal Clichy Cedex , FR 92117 NOL-DO 53ED-06 856058184430 SHAMPOO 18-AUG-2007 COSMETLBLG India 077-7002473-0 1 1 Radico Faridabad Haryana, IN 121002 NYK-DO 53ED-06 HERBAL SHAMPOO 24-AUG-2007 UNAPPROVED India DZ1-0352892-0 7 1 Hsahnaz Herbals New Delhi , IN SAN-DO 53ED-06 SHAHNAZ HUSAIN'S ARNICA SHAMPOO (500ML) (NFMU) 24-AUG-2007 UNSAFE COL COSMETLBLG India HA9-0700122-6 18 1 Shri Ramtirth Yogashram Dadar , IN 400014 LOS-DO 53ED-07 BRAHMI OIL 22-AUG-2007 NOT LISTED UNAPPROVED India K80-0933787-5 13 1 Ashiwin Fine Chemical & Pharmaceutical Kashi Mira , IN SAN-DO 53ED-07 EUCALIPTUS OIL I.P. 30-AUG-2007 CSTIC LBLG India AYG-1001160-4 28 1 Unique Fragrances Delhi D, IN 110034 SAN-DO 53ED-99 KEO KARPIN HAIR OIL 14-AUG-2007 UNSAFE COL COSMETLBLG India AYG-1001160-4 30 1 Unique Fragrances Delhi D, IN 110034 SAN-DO 53ED-99 KEO KARPIN HAIR OIL 14-AUG-2007 UNSAFE COL COSMETLBLG India AYG-1001160-4 75 1 Dabur India Ltd Uttaranchal , IN SAN-DO 53ED-99 AMLA HAIR OIL 14-AUG-2007 CSTIC LBLG COSMETLBLG India AYG-1001160-4 76 1 Dabur India Ltd Uttaranchal , IN SAN-DO 53ED-99 AMLA HAIR OIL 14-AUG-2007 CSTIC LBLG COSMETLBLG India AYG-1001160-4 77 1 Dabur India LTD Jammu , IN 181 133 SAN-DO 53ED-99 SPECIAL HAIR OIL 14-AUG-2007 CSTIC LBLG COSMETLBLG India AYG-1001160-4 78 1 Dabur India LTD Jammu , IN 181 133 SAN-DO 53ED-99 SPECIAL HAIR OIL 14-AUG-2007 COLOR LBLG COSMETLBLG India DZ1-0352892-0 3 2 Hsahnaz Herbals New Delhi , IN SAN-DO 53ED-99 SHAHNAZ HUSAIN'S ARNICA HAIR OIL (500ML) (NFMU) 24-AUG-2007 UNSAFE COL Spain 112-5348190-9 1 3 L'Oreal Barcolona , ES NOL-DO 53FD-99 856058184430 HAIR COLORING PREP 18-AUG-2007 CSTIC LBLG COSMETLBLG United Arab Emirates 110-8681827-9 5 1 Highlight Airfreig Dubai , AE CIN-DO 53FH-02 FACE CREAM AND LOTION 13-AUG-2007 UNSAFE COL Pakistan 112-7519631-1 1 1 Najma Mehndi Karachi , PK NOL-DO 53FY-02 728096480030 HENNA 15-AUG-2007 COSM COLOR CSTIC LBLG Kenya 112-7311820-0 1 1 Tola Adam Mombasa , KE NOL-DO 53FY-02 861118364648 HENNA 29-AUG-2007 COSM COLOR CSTIC LBLG COSMETLBLG Canada 551-6982374-2 2 1 B Demco Manufacturing Inc Saint-hubert Quebec, CA J3Y2S3 NYK-DO 53GD-09 Orange Face Paint 08-AUG-2007 COSM COLOR CONTAINER Australia AEK-7699445-4 1 1 Zimmermann Zetland , AU 2017 LOS-DO 53GK-05 COSMETIC LIP GLOSS 10-AUG-2007 CSTIC LBLG India 112-7366986-3 1 1 Bhavi Tubes & Cont Mumbai , IN SEA-DO 53IC-01 860303112034 CLEAN&FRESH TOOTHPASTE SAMPLE 17-AUG-2007 NOT LISTED LACKS FIRM LABELING India 112-7366986-3 1 2 Bhavi Tubes & Cont Mumbai , IN SEA-DO 53IC-01 860303112034 CLEAN&FRESH TOOTHPASTE SAMPLE 17-AUG-2007 NOT LISTED LACKS FIRM LABELING China GF5-0956423-3 41 1 Zhejiang Bohai Import And Export Co., Ltd. Zhejiang , CN ATL-DO 53IY-01 TOOTHPASTE 23-AUG-2007 NOT LISTED Nigeria J11-0040553-6 7 1 C Adefolorunsho Tech. Ent. Ogun State , NG SWI-DO 53JK-01 Antiseptic Soap 30-AUG-2007 NOT LISTED China GF5-0956423-3 32 1 Zhejiang Bohai Import And Export Co., Ltd. Zhejiang , CN ATL-DO 53JY-99 HAND SOAP 23-AUG-2007 UNAPPROVED United Kingdom 112-5958239-5 10 1 Hive Beauty Tamworth , GB NOL-DO 53LC-01 904376761184 CLEANSE CREAM 01-AUG-2007 CSTIC LBLG Belgium 112-5958239-5 1 4 Hive Of Beauty Europe Bvba Temse , BE NOL-DO 53LC-02 904376761184 WAX 01-AUG-2007 CSTIC LBLG Dominican Republic WX8-4913417-5 3 1 Laboratorios Key C Por A Santo Domingo , DO SJN-DO 53LC-03 FACIAL CREAM- WHITENNING CREAM 08-AUG-2007 POISONOUS Spain 508-0302345-1 6 2 Cristian Lay S.A. Badajoz, Espana , ES SJN-DO 53LC-03 BODY CREAM 09-AUG-2007 UNAPPROVED United States 310-1168943-3 1 1 Worldwide Science Englewood Cliffs, NJ 07632 NYK-DO 53LC-03 SPF 30 Defense Day Cream 23-AUG-2007 NOT LISTED Italy 112-7396897-6 1 1 Agami Srl Roma , IT 50175 NOL-DO 53LC-03 860454310946 ETERNITE SKIN CREAM 30-AUG-2007 CSTIC LBLG Italy 112-7396897-6 1 2 Agami Srl Roma , IT 50175 NOL-DO 53LC-03 860454310946 SKIN CREAM 30-AUG-2007 CSTIC LBLG Belgium 112-5958239-5 9 5 Hive Of Beauty Europe Bvba Temse , BE NOL-DO 53LC-06 904376761184 SKIN CARE PRODUCT 01-AUG-2007 COSM COLOR France 112-5958239-5 11 6 Hive Of Beauty Technature Dirinon , FR 29460 NOL-DO 53LC-06 904376761184 LOTION 01-AUG-2007 CSTIC LBLG Mexico DM0-0907067-1 1 1 B Reduplex, S.A. De C.V. San Nicolas De Los Garza Nl , MX 66466 SWI-DO 53LC-06 Body Gel 08-AUG-2007 COSM COLOR France HK8-7191743-9 2 6 Caudalie Paris , FR 75017 SWI-DO 53LC-06 CONTOUR CREAM EYES and LIPS 29-AUG-2007 UNAPPROVED France HK8-7191743-9 2 27 Caudalie Paris , FR 75017 SWI-DO 53LC-06 CONTOURING CREAM 29-AUG-2007 UNAPPROVED France HK8-7193088-7 1 4 Caudalie Paris , FR 75017 SWI-DO 53LC-06 CONTOUR CREAM EYES & LIPS 31-AUG-2007 UNAPPROVED France HK8-7193088-7 1 17 Caudalie Paris , FR 75017 SWI-DO 53LC-06 CONTOURING CREAM 31-AUG-2007 UNAPPROVED Belgium 112-7567368-1 1 1 Hive Of Beauty Europe , BE NOL-DO 53LC-08 904376764882.FACE MAKEUP PURIFYING MASQUE 15-AUG-2007 COSMETLBLG Italy 112-7396897-6 1 5 Agami Srl Roma , IT 50175 NOL-DO 53LC-08 860454310946 COLLAGENE PLUS NIGHT CREAM 30-AUG-2007 CSTIC LBLG France HK8-7191743-9 2 10 Caudalie Paris , FR 75017 SWI-DO 53LC-10 VINOSOURCE ANIT WRINKLE NOURISHING CREAM 29-AUG-2007 UNAPPROVED France HK8-7191743-9 2 11 Caudalie Paris , FR 75017 SWI-DO 53LC-10 VINOSOURCE RICHE ANTIWRINKLE ULTRA NOURISHING CREAM 29-AUG-2007 UNAPPROVED France HK8-7193088-7 1 1 Caudalie Paris , FR 75017 SWI-DO 53LC-10 VINOSOURCE ANTI-WRINKLE CREAM/C40-4 31-AUG-2007 UNAPPROVED United Kingdom 112-7338281-4 1 1 Something Italian Oxford GB-OXF, GB OX27SH NOL-DO 53LC-99 929206104966/ANTI-AGE DAY CREAM 30-AUG-2007 UNSAFE COL Belgium 112-5958239-5 1 5 Hive Of Beauty Europe Bvba Temse , BE NOL-DO 53LD-02 904376761184 WAX 01-AUG-2007 CSTIC LBLG France HK8-7191743-9 2 28 Caudalie Paris , FR 75017 SWI-DO 53LD-03 FIRMING CONCENTRATE 29-AUG-2007 UNAPPROVED France HK8-7193088-7 1 18 Caudalie Paris , FR 75017 SWI-DO 53LD-03 FIRMING CONCENTRATE 31-AUG-2007 UNAPPROVED United Kingdom 112-7465659-6 1 1 Skin Culture London , GB NOL-DO 53LD-06 860856420369/AFTERCARE KITS 15-AUG-2007 CSTIC LBLG Spain 508-0302220-6 6 2 C Cristian Lay S.A. Badajoz, Espana , ES SJN-DO 53LD-99 anti-cellulite gel body choc 09-AUG-2007 UNAPPROVED Spain 508-0302220-6 6 2 D Cristian Lay S.A. Badajoz, Espana , ES SJN-DO 53LD-99 flat abdomen body choc 09-AUG-2007 UNAPPROVED Spain 508-0302220-6 6 2 E Cristian Lay S.A. Badajoz, Espana , ES SJN-DO 53LD-99 anti-cellulite body choc 09-AUG-2007 UNAPPROVED China 112-5958239-5 3 1 Hive Of Beauty China Kowloon , CN NOL-DO 53LY-02 904376761184 WAX 01-AUG-2007 CSTIC LBLG Spain 508-0302556-3 6 1 P Cristian Lay S.A. Badajoz, Espana , ES SJN-DO 53LY-99 Plane Tummy Gell with cacao extract 10-AUG-2007 UNAPPROVED Spain 508-0302556-3 6 1 Q Cristian Lay S.A. Badajoz, Espana , ES SJN-DO 53LY-99 Body Choc Plane Tummy Gel with cacao extract 10-AUG-2007 UNAPPROVED Italy 112-7396897-6 1 4 Agami Srl Roma , IT 50175 NOL-DO 53PY-99 860454310946 ANTISTRESS 30-AUG-2007 CSTIC LBLG French Polynesia AB8-0064071-1 3 1 Parfumerie Tiki Papeete , PF SEA-DO 53YC-99 TAMANU BALM 15-AUG-2007 UNAPPROVED India AYG-1001160-4 13 1 Unique Fragrances Delhi D, IN 110034 SAN-DO 53YH-99 SUPREME AISHWARYA HEENA 14-AUG-2007 COSM COLOR CSTIC LBLG China 112-5958239-5 8 1 Hive Of Beauty China Kowloon , CN NOL-DO 53YY-02 904376761184 BRUSH 01-AUG-2007 CSTIC LBLG United Kingdom 112-5958239-5 7 1 Hive Beauty Tamworth , GB NOL-DO 53YY-03 904376761184 BRUSH 01-AUG-2007 CSTIC LBLG Sweden 112-7472223-2 1 1 Q-Med AB Uppsala , SE SE 752-28 DET-DO 53YY-99 790790543538 RESTYLANE BEAUTY INJECTION 08-AUG-2007 RXPERSONAL Kenya 112-7753444-4 1 1 Abdi Hakim Nairobi , KE NOL-DO 53YY-99 926314276683 BODY DYE 24-AUG-2007 UNSAFE COL