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
France XXX-0152493-4 1 5 Laboratoire Ht26 Paris , FR 75010 ATL-DO 53AD-02 HT26 Paris (Anti -Spot) Lotion/ body milk 07-MAR-2008 CSTIC LBLG Togo XXX-0152493-4 1 3 Picos Lome , TG ATL-DO 53AD-02 Lait De Beaute Esclaircissant (Bio 26) 07-MAR-2008 LABELING COSMETLBLG United Kingdom 946-0605102-0 206 1 Sara Lee Household & Body Care Slough FN, GB LOS-DO 53BD-01 RADOX STRESS RELIEF HERBAL BATH SOAP 500ML/6BO 20-MAR-2008 LACKS N/C UNAPPROVED Korea, Republic Of (South) WIB-1212918-8 32 1 Hanbul Cosmetics Co. Seoul , KR LOS-DO 53CC-04 LUICHEL E GOLDEN RICH EYE BALM 27-MAR-2008 UNAPPROVED France 554-3421327-2 2 1 Institut Esthederm Paris , FR BLT-DO 53CC-05 CYCLO REFINER GL YOUTH EYE CR JAR 0.5OZ 26-MAR-2008 UNAPPROVED Taiwan ANP-0009073-9 8 1 Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO 53CC-08 EYEBROW PENCIL 04-MAR-2008 COSM COLOR Pakistan XXX-0151310-1 1 1 A.Q. & Company Karachi , PK ATL-DO 53CG-02 Kajal eyeliner (Hashmi) 13-MAR-2008 UNSAFE COL Germany P09-3045001-3 3 1 Helena Rubinstein Inc Etkrath Unterfeldhauf De , DE 4006 LOS-DO 53CK-02 KHOL EYE PENCIL BRUN 05-MAR-2008 UNSAFE COL Germany P09-3045001-3 3 2 Helena Rubinstein Inc Etkrath Unterfeldhauf De , DE 4006 LOS-DO 53CK-02 KHOL EYE PENCIL NOIR 05-MAR-2008 UNSAFE COL Germany P09-3044734-0 2 1 Helena Rubinstein Inc Etkrath Unterfeldhauf De , DE 4006 LOS-DO 53CK-02 KHOL EYE PENCIL BRUN 05-MAR-2008 UNSAFE COL Germany P09-3044734-0 2 2 Helena Rubinstein Inc Etkrath Unterfeldhauf De , DE 4006 LOS-DO 53CK-02 KHOL EYE PENCIL NOIR 05-MAR-2008 UNSAFE COL Germany P09-3044833-0 2 1 Helena Rubinstein Inc Etkrath Unterfeldhauf De , DE 4006 LOS-DO 53CK-02 KHOL EYE PENCIL BRUN 05-MAR-2008 UNSAFE COL Germany P09-3044833-0 2 2 Helena Rubinstein Inc Etkrath Unterfeldhauf De , DE 4006 LOS-DO 53CK-02 KHOL EYE PENCIL NOIR 05-MAR-2008 UNSAFE COL Germany P09-3044824-9 2 1 Helena Rubinstein Inc Etkrath Unterfeldhauf De , DE 4006 LOS-DO 53CK-02 KHOL EYE PENCIL BRUN 05-MAR-2008 UNSAFE COL Germany P09-3044824-9 2 2 Helena Rubinstein Inc Etkrath Unterfeldhauf De , DE 4006 LOS-DO 53CK-02 KHOL EYE PENCIL NOIR 05-MAR-2008 UNSAFE COL Germany 112-5907677-5 3 1 Swan Stabilo Heroldsberg , DE 90562 NYK-DO 53CK-02 EYE PENCIL 19-MAR-2008 POISONOUS Germany 112-5907677-5 22 1 Swan Stabilo Heroldsberg , DE 90562 NYK-DO 53CK-02 EYE PENCIL 19-MAR-2008 POISONOUS Germany 112-5907677-5 45 1 Swan Stabilo Heroldsberg , DE 90562 NYK-DO 53CK-02 EYE PENCIL 19-MAR-2008 POISONOUS Germany 112-5907677-5 51 1 Swan Stabilo Heroldsberg , DE 90562 NYK-DO 53CK-02 EYE PENCIL 19-MAR-2008 POISONOUS Japan ANP-0009117-4 15 1 A Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO 53DD-02 Cool Sheet 03-MAR-2008 CSTIC LBLG LABELING China 231-7152327-0 18 1 Yumark Enterprises Co.,Ltd Guangzhouguangzhou , CN 509999 CHI-DO 53DH-03 2710 @COSMETICS - BODY MA 03-MAR-2008 UNSAFE COL China 231-7152327-0 18 2 Yumark Enterprises Co.,Ltd Guangzhouguangzhou , CN 509999 CHI-DO 53DH-03 2710 @COSMETICS - BODY M 03-MAR-2008 UNSAFE COL France 112-1677222-1 1 1 Henkel France Boulogne Billancourt , FR 92100 NOL-DO 53EA-02 862031264680/ OSIS SPARKLER 20-MAR-2008 CSTIC LBLG LABELING France 112-1677222-1 1 2 Henkel France Boulogne Billancourt , FR 92100 NOL-DO 53EA-02 BC Bonacure hair therapy 20-MAR-2008 CSTIC LBLG LABELING France 112-1677222-1 1 3 Henkel France Boulogne Billancourt , FR 92100 NOL-DO 53EA-02 OSIS Syick Up 20-MAR-2008 CSTIC LBLG LABELING France 112-1677222-1 1 4 Henkel France Boulogne Billancourt , FR 92100 NOL-DO 53EA-02 Osis 4-Play 20-MAR-2008 CSTIC LBLG LABELING France 112-1677222-1 1 5 Henkel France Boulogne Billancourt , FR 92100 NOL-DO 53EA-02 OSIS+ Shape 20-MAR-2008 CSTIC LBLG LABELING France 112-1677222-1 1 6 Henkel France Boulogne Billancourt , FR 92100 NOL-DO 53EA-02 SILHOUETTE PURE FORMULA invisable hold 20-MAR-2008 CSTIC LBLG LABELING Spain BTL-0010451-2 19 1 Almenar Exportaciones, S.L. Valencia , ES SJN-DO 53ED-05 FACE MASK 05-MAR-2008 UNAPPROVED Togo XXX-0152493-4 1 2 Lux Beaute Bamako Unknown , TG ATL-DO 53ED-06 Plaisir A3 Lait Eclaircissant (shampoo) 07-MAR-2008 LABELING Canada 336-4242534-5 1 1 A Nisim International Brampton ON, CA L6T4M4 NYK-DO 53ED-06 SHAMPOO 2 oz 26-MAR-2008 COSMETLBLG Canada 336-4242534-5 1 1 B Nisim International Brampton ON, CA L6T4M4 NYK-DO 53ED-06 SHAMPOO 8 oz 26-MAR-2008 COSMETLBLG Canada 336-4242534-5 1 1 E Nisim International Brampton ON, CA L6T4M4 NYK-DO 53ED-06 SHAMPOO SAMPLES 26-MAR-2008 COSMETLBLG India KM6-0102815-2 19 1 Veerprabhu Export House Mumbai , IN 400003 BLT-DO 53ED-07 COCONUT HAIR OIL 25-MAR-2008 CSTIC LBLG India KM6-0102815-2 19 2 Veerprabhu Export House Mumbai , IN 400003 BLT-DO 53ED-07 COCNUT HAIR OIL 25-MAR-2008 CSTIC LBLG India KM6-0102815-2 19 3 Veerprabhu Export House Mumbai , IN 400003 BLT-DO 53ED-07 COCONUT HAIR OIL 25-MAR-2008 CSTIC LBLG India KM6-0102815-2 22 2 Veerprabhu Export House Mumbai , IN 400003 BLT-DO 53ED-07 SIMCO HAIR FIXTURE 25-MAR-2008 CSTIC LBLG India KM6-0102815-2 22 3 Veerprabhu Export House Mumbai , IN 400003 BLT-DO 53ED-07 SIMCO HAIR FIXTURE 25-MAR-2008 CSTIC LBLG India KM6-0102815-2 22 4 Veerprabhu Export House Mumbai , IN 400003 BLT-DO 53ED-07 SIMCO HAIR FIXTURE 25-MAR-2008 CSTIC LBLG Canada 336-4242534-5 4 1 Nisim International Brampton ON, CA L6T4M4 NYK-DO 53ED-99 KALO INGROWN HAIR TREATMENT 26-MAR-2008 COSMETLBLG Canada 336-4242534-5 2 1 A Nisim International Brampton ON, CA L6T4M4 NYK-DO 53EY-01 HAIR CONDITIONER 8 oz 26-MAR-2008 COSMETLBLG Canada 336-4242534-5 2 1 B Nisim International Brampton ON, CA L6T4M4 NYK-DO 53EY-01 HAIR CONDITIONER Litre 26-MAR-2008 COSMETLBLG Canada 336-4242534-5 2 1 C Nisim International Brampton ON, CA L6T4M4 NYK-DO 53EY-01 FAST CONDITIONER 26-MAR-2008 COSMETLBLG Canada 336-4242534-5 2 1 D Nisim International Brampton ON, CA L6T4M4 NYK-DO 53EY-99 HAIR LOSS SURVIVAL KIT 26-MAR-2008 COSMETLBLG Canada 336-4242534-5 3 1 A Nisim International Brampton ON, CA L6T4M4 NYK-DO 53EY-99 HAIR AND SCALP EXTRACTS 26-MAR-2008 COSMETLBLG United Arab Emirates 112-1825576-1 5 1 Somalia Star Trading Deria , AE NOL-DO 53FD-01 901814935649 HENNA 28-MAR-2008 COSMETLBLG Mexico BVK-0023844-9 7 1 B Colgate Palmolive SA de CV Mexico City , MX 11500 SWI-DO 53FD-04 Shampoo (Caprice Manazana) 03-MAR-2008 COLOR LBLG Korea, Republic Of (South) WIB-1212918-8 34 1 Hanbul Cosmetics Co. Seoul , KR LOS-DO 53GC-06 LUICHEL SHINY W BASE 27-MAR-2008 UNAPPROVED China 231-7159208-5 17 1 Almar China Guangdong , CN CHI-DO 53GC-12 ALMAR LIPGLOSS IN POUCH 24-MAR-2008 UNSAFE COL COSM COLOR Taiwan EG6-1438153-1 2 1 Jia Hsing Enterprise Co.,Ltd. Changhua , TW 50600 NYK-DO 53GG-05 Smile Brightening Lip Treatment 28-MAR-2008 COSM COLOR COSMETLBLG China CDU-0801128-5 5 1 Superier Traders International Ltdll Be Added Taipei, Taiwan , C CHI-DO 53GI-05 MAKE-UP PREP,LIPSTICK,NOT FOR EYES 06-MAR-2008 COSM COLOR China 231-7152327-0 36 1 A+B Cosmetics Co. Dongguan, Guangdong , CN CHI-DO 53GK-05 2703 @COSMETICS - LIP MA 03-MAR-2008 UNSAFE COL China 231-7152327-0 36 2 A+B Cosmetics Co. Dongguan, Guangdong , CN CHI-DO 53GK-05 2703 @COSMETICS - LIP MAK 03-MAR-2008 UNSAFE COL China 682-2502187-9 5 1 Zhejiang Yasi Cosmetics Co Yiwu , CN SEA-DO 53GK-05 LIP BALM 24-MAR-2008 CSTIC LBLG Korea, Republic Of (South) ANP-0008965-7 17 1 B Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO 53ID-02 MOUTHWASH 03-MAR-2008 CSTIC LBLG Korea, Republic Of (South) ANP-0008993-9 20 1 Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO 53ID-02 MOUTH WASH 03-MAR-2008 CSTIC LBLG China GV8-0103793-0 1 1 Holly Ind Prod Co Ltd Ningboningbo , CN 315000 LOS-DO 53IG-99 WHITENING GEL, 25 RETAIL PKG/CTN, 250 G/PKG NET, 275 G/PKG G 18-MAR-2008 NO 510(K) India HA9-0700163-0 20 1 Vicco laboratories Hinga Nagpur, IN 440016 LOS-DO 53IH-01 Vajradanti Powder - Ayurvedic Medicine 19-MAR-2008 UNAPPROVED Germany EI5-5495507-6 1 1 Unilever Lever Faberge Deutschland Mannheim , DE 68219 NYK-DO 53JB-01 Dove Bar Soap 03-MAR-2008 COSM COLOR COSMETLBLG Mexico BVK-0023844-9 3 1 A Unilever de Mexico S.A. de C.V. Tultitlan Mx-Mex, MX 54900 SWI-DO 53LC-01 Body Cream (PONDS Suavizante) 03-MAR-2008 CSTIC LBLG Mexico BVK-0023844-9 5 1 A Colgate Palmolive SA de CV Mexico City , MX 11500 SWI-DO 53LC-01 Hinds Body Cream (Rosa Piel Reseca) 03-MAR-2008 COLOR LBLG France 554-3421327-2 1 4 Institut Esthederm Paris , FR BLT-DO 53LC-03 WHITE R N IGHT REFINER CREAM JAR 1.7 OZ 26-MAR-2008 UNAPPROVED Poland 112-1670787-0 1 1 Energy Cosmetic Lominaki , PL NOL-DO 53LC-10 Repair Complex #1 18-MAR-2008 LABELING Poland 112-1670787-0 1 2 Energy Cosmetic Lominaki , PL NOL-DO 53LC-10 799807376162/EMULSION 18-MAR-2008 LABELING Argentina 112-1720860-5 1 1 Marcelo Futerman Santa Fe , AR NOL-DO 53LC-99 ESTRIA NON CREMA 13-MAR-2008 CSTIC LBLG COSMETLBLG Argentina 112-1720165-9 1 1 Marcelo Futerman Santa Fe , AR NOL-DO 53LC-99 ESTRIA NON CREMA 18-MAR-2008 CSTIC LBLG COSMETLBLG Argentina 112-1720165-9 1 2 Marcelo Futerman Santa Fe , AR NOL-DO 53LC-99 EXTRA FIRM 18-MAR-2008 CSTIC LBLG COSMETLBLG United Kingdom 946-0605102-0 203 1 Reckitt Benkiser Ltd Swindon , GB SN57XZ LOS-DO 53LC-99 DETTOL ANTISEPTIC-DISINFECTANT LIQUID 500ML/6BO 20-MAR-2008 LACKS N/C UNAPPROVED Poland 112-1670787-0 1 4 Energy Cosmetic Lominaki , PL NOL-DO 53LD-03 Slim and Shape. 18-MAR-2008 LABELING Poland DP4-0420814-3 1 1 Lowell International Polska Sp. Z.Oo Olsztyn , PL NYK-DO 53LD-06 Olive Moisturizing Cream 06-MAR-2008 CSTIC LBLG Poland DP4-0420814-3 2 7 Lowell International Polska Sp. Z.Oo Olsztyn , PL NYK-DO 53LD-06 Eye Make-Up Remover Lotion 06-MAR-2008 UNSAFE COL CSTIC LBLG Korea, Republic Of (South) WIB-1212918-8 33 1 Hanbul Cosmetics Co. Seoul , KR LOS-DO 53LD-06 LUICHEL W NUTRY EMULSION 27-MAR-2008 UNAPPROVED Korea, Republic Of (South) WIB-1212918-8 35 1 Hanbul Cosmetics Co. Seoul , KR LOS-DO 53LD-06 LUICHEL W SILKY SERUM 27-MAR-2008 UNAPPROVED Australia UPS-0523818-1 1 1 Vani-T Pty Ltd Lonsdalelonsdale , AU 5160 CIN-DO 53MD-01 SUN TAN LIQUID 28-MAR-2008 COSM COLOR Japan 112-8814121-3 1 1 Daito Kasei Kogyo Co Ltd Osaka , JP 535 NOL-DO 53PD-99 859955321994 NFCB-3D-1R (Raw Material for Cosmetics) 07-MAR-2008 COLOR LBLG Germany 279-0145745-0 1 1 Rovi Cosmetics Intern. Gmbh Schluchtern , DE 36381 LOS-DO 53PD-99 RETINOL 50C 26-MAR-2008 CSTIC LBLG LABELING COSMETLBLG COSMETLBLG Germany 279-0145745-0 2 1 Rovi Cosmetics Intern. Gmbh Schluchtern , DE 36381 LOS-DO 53PD-99 EMPROVE (CAFFEINE) 26-MAR-2008 NOT LISTED COSMETLBLG COSMETLBLG Germany 279-0145745-0 3 1 Rovi Cosmetics Intern. Gmbh Schluchtern , DE 36381 LOS-DO 53PD-99 PHOSPHOLIPON 85 G 26-MAR-2008 NOT LISTED COSMETLBLG COSMETLBLG Germany 279-0145745-0 5 1 A Rovi Cosmetics Intern. Gmbh Schluchtern , DE 36381 LOS-DO 53PD-99 1,2 PENTANDIOL 26-MAR-2008 NOT LISTED COSMETLBLG COSMETLBLG Germany 279-0145745-0 5 1 B Rovi Cosmetics Intern. Gmbh Schluchtern , DE 36381 LOS-DO 53PD-99 PHOSPHOLIPON 90 H(L) 26-MAR-2008 NOT LISTED COSMETLBLG COSMETLBLG Germany 279-0145745-0 5 1 C Rovi Cosmetics Intern. Gmbh Schluchtern , DE 36381 LOS-DO 53PD-99 JAPANWACHS LT 845 26-MAR-2008 NOT LISTED COSMETLBLG Germany 279-0145745-0 5 1 D CORUM INC TAIPEI Neihu, TW LOS-DO 53PD-99 CORUM 9235 26-MAR-2008 NOT LISTED COSMETLBLG COSMETLBLG China ND7-0053478-4 1 1 Beijing Brighty Instrument Co Beijing , CN 100088 LOS-DO 53PH-99 ARBUTIN 18-MAR-2008 UNSFDIETSP Kenya 112-8661749-5 1 1 Aman Mohd Mombasa , KE NOL-DO 53YH-99 861118382132 HENNA 11-MAR-2008 COSM COLOR China AT2-0029950-4 2 1 Chenghai Daeryi Toys Factory Guangdong , CN LOS-DO 53YY-99 Cosmetics Series Let You More Beauty 19-MAR-2008 UNSAFE COL