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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 66-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
DP4-0588052-8/4/1 23-Aug-2012 66FBY99 2000040724 Casa Angola Internacional, Importacao e Exportacao SA Portugal
 
112-8733756-7/1/2 09-Aug-2012 66JCA01 3006781192 Acme Formulation Pyt Ltd India
 
AEK-0312169-2/1/1 30-Aug-2012 66JCA01 3009706113 Bahadur Singh India
 
XXX-0290341-8/1/1 01-Aug-2012 66JCY01 3003235031 MERCK-MEXICO S.A. Mexico
 
AEK-0308668-9/2/1 10-Aug-2012 66LAM99 3009641325 Batras Positive Health Clinic India
 
D52-4797542-3/1/3 06-Aug-2012 66PAK99 3009611896 Batab Healtcare Mexico
 
231-3345781-6/2/8 03-Aug-2012 66PBJ99 3007903996 She Corporation Pty Ltd Australia
 
231-3345781-6/1/8 03-Aug-2012 66PBJ99 3007903996 She Corporation Pty Ltd Australia
 
231-3345781-6/3/8 03-Aug-2012 66PBJ99 3007903996 She Corporation Pty Ltd Australia
 
231-3345781-6/4/8 03-Aug-2012 66PBJ99 3007903996 She Corporation Pty Ltd Australia
 
231-3346134-7/3/8 03-Aug-2012 66PBJ99 3007903996 She Corporation Pty Ltd Australia
 
231-3346134-7/5/8 03-Aug-2012 66PBJ99 3007903996 She Corporation Pty Ltd Australia
 
231-3346134-7/4/8 03-Aug-2012 66PBJ99 3007903996 She Corporation Pty Ltd Australia
 
231-3346134-7/6/8 03-Aug-2012 66PBJ99 3007903996 She Corporation Pty Ltd Australia
 
112-8466656-2/1/3 27-Aug-2012 66PBJ99 3006188208 The Skin Food Korea, Republic Of (South)
 
112-8466656-2/1/4 27-Aug-2012 66PBJ99 3005578160 Glaxosmithkline Pte Ltd Singapore
 
AEK-0407686-1/1/1 15-Aug-2012 66PBL10 3008907503 Rt Magique Mexico
 
AEK-0407697-8/1/1 15-Aug-2012 66PBL10 3008907503 Rt Magique Mexico
 
112-8514863-6/4/8 15-Aug-2012 66PBL99 3009643086 Rituals Cosmetics Enterprise Denmark
 
112-8514863-6/4/13 15-Aug-2012 66PBL99 3009643086 Rituals Cosmetics Enterprise Denmark
 
112-8514863-6/4/12 15-Aug-2012 66PBL99 3009643086 Rituals Cosmetics Enterprise Denmark
 
112-8514863-6/4/11 15-Aug-2012 66PBL99 3009643086 Rituals Cosmetics Enterprise Denmark
 
112-8514863-6/4/10 15-Aug-2012 66PBL99 3009643086 Rituals Cosmetics Enterprise Denmark
 
112-8514863-6/4/9 15-Aug-2012 66PBL99 3009643086 Rituals Cosmetics Enterprise Denmark
 
101-9787404-2/23/1 21-Aug-2012 66PBL99 3004975024 John Masters Organics Hair Care United States
 
112-8146216-3/2/1 07-Aug-2012 66PBY99 3004181110 Skin Sciences Laboratory, Inc. Philippines
 
H41-2553634-6/1/1 02-Aug-2012 66V99 3004258294 BIOCODEX (HQ) France
 
H41-2553634-6/2/1 02-Aug-2012 66V99 3004258294 BIOCODEX (HQ) France
 
UPS-7303528-5/1/1 22-Aug-2012 66V99 3007225366 Herbal Technologies Bv Netherlands
 
J89-0115765-3/1/2 14-Aug-2012 66VAJ99 3006345820 MAXROTH IMPEX PVT LTD India
 
112-8578238-4/1/1 31-Aug-2012 66VAK99 3009611874 Telemart Shopping India
 
112-8278271-8/7/1/A 10-Aug-2012 66VAL99 3005742067 Al Harmoodi Computer Systems United Arab Emirates
 
EG6-2665862-9/1/1 13-Aug-2012 66VAL99 3007389902 Brands International Corp Canada
 
AEK-0203469-8/1/1 09-Aug-2012 66VAQ99 3009546771 Hl Healthcare Ltd United Kingdom
 
AEK-0307774-6/1/1 03-Aug-2012 66VAY99 3009626084 Asante,George Ghana
 
ANP-0035936-5/6/1/A 03-Aug-2012 66VAY99 3005343638 Daiso Industries Co Ltd Japan
 
ANP-0035936-5/6/1/C 03-Aug-2012 66VAY99 3005343638 Daiso Industries Co Ltd Japan
 
ANP-0035936-5/6/1/D 03-Aug-2012 66VAY99 3005343638 Daiso Industries Co Ltd Japan
 
ANP-0035936-5/6/1/E 03-Aug-2012 66VAY99 3005343638 Daiso Industries Co Ltd Japan
 
112-8570815-7/1/1 09-Aug-2012 66VAY99 3008855266 Shree Marwal Sevashram India
 
AEK-0308381-9/1/1 09-Aug-2012 66VAY99 3008902822 Kundan Kidney Care Centre India
 
AEK-0308457-7/1/1 09-Aug-2012 66VAY99 3009637857 Sk Ayurveda India
 
D52-0949413-2/1/7 14-Aug-2012 66VAY99 3005485730 Far Favour Enterprises Ltd., China
 
D52-0949413-2/1/8 14-Aug-2012 66VAY99 3005485730 Far Favour Enterprises Ltd., China
 
D52-0949413-2/1/9 14-Aug-2012 66VAY99 3005485730 Far Favour Enterprises Ltd., China
 
J89-0115765-3/1/1 14-Aug-2012 66VAY99 3006852558 Amrutanjan Health Care Ltd India
 
ANP-0035936-5/6/1/B 27-Aug-2012 66VAY99 3005343638 Daiso Industries Co Ltd Japan
 
112-8748143-1/1/1 06-Aug-2012 66VBA99 3009668440 Medichin Nv Belgium
 
112-8490227-2/1/1 14-Aug-2012 66VBA99 3008489920 Akums Drugs & Pharma India
 
112-2282512-2/1/1 31-Aug-2012 66VBH99 3008921059 Ashu Herbal India
 
112-8748903-8/4/1 03-Aug-2012 66VBJ99 3004897154 Nashwan Perfumes United Arab Emirates
 
BBH-3016105-9/1/1 03-Aug-2012 66VBJ99 3009453761 Charming Girl Trading Taiwan
 
112-8421325-8/1/1 09-Aug-2012 66VBJ99 3009611874 Telemart Shopping India
 
J89-0115765-3/1/4 14-Aug-2012 66VBJ99 3008767092 Paras Pharmaceutical Ltd India
 
J89-0115765-3/1/5 14-Aug-2012 66VBJ99 3006345820 MAXROTH IMPEX PVT LTD India
 
J89-0115765-3/1/6 14-Aug-2012 66VBJ99 3006345820 MAXROTH IMPEX PVT LTD India
 
J89-0115765-3/1/8 14-Aug-2012 66VBJ99 3006480587 Emami Limited India
 
J89-0115765-3/1/10 14-Aug-2012 66VBJ99 3004980754 G.D. Pharmaceuticals Private Limited India
 
J89-0115765-3/1/29 14-Aug-2012 66VBJ99 3006115568 Shah Maganlal Chunilal Gandhi India
 
J89-0115765-3/1/28 14-Aug-2012 66VBK99 3007168274 Dabur India Ltd India
 
J89-0115765-3/3/15 14-Aug-2012 66VBK99 3004571592 Sheth Brothers India
 
J89-0115765-3/1/14 14-Aug-2012 66VBL99 3004326829 Dabur India Limited India
 
J89-0115765-3/1/26 14-Aug-2012 66VBL99 3008466109 Dhanvantari Guj Herb India
 
J89-0115765-3/1/27 14-Aug-2012 66VBL99 3004326849 Dabur India Limited India
 
EPU-0032240-0/1/1 28-Aug-2012 66VBL99 3010178058 Herbolaris Internacional Mexico
 
112-8346742-6/1/1 14-Aug-2012 66VBO99 3008855266 Shree Marwal Sevashram India
 
BBH-3016105-9/1/8 03-Aug-2012 66VBV99 3009652050 Morita Biotech Corp. Taiwan
 
BBH-3016105-9/1/4 03-Aug-2012 66VBY99 3009453761 Charming Girl Trading Taiwan
 
BBH-3016105-9/1/9 03-Aug-2012 66VBY99 3009453761 Charming Girl Trading Taiwan
 
BBH-3016105-9/1/11 03-Aug-2012 66VBY99 3009453761 Charming Girl Trading Taiwan
 
267-1303038-0/1/28 10-Aug-2012 66VBY99 3003639262 Kaiser Pharmaceutical Co. Taiwan
 
EQF-0000293-3/1/11 13-Aug-2012 66VBY99 3009613676 Cheongwoo Co Ltd Korea, Republic Of (South)
 
EQF-0000293-3/1/12 13-Aug-2012 66VBY99 3009613676 Cheongwoo Co Ltd Korea, Republic Of (South)
 
J34-0067373-0/3/1 14-Aug-2012 66VBY99 3002518618 Guangzhou Xingqun Pharmaceutical Co Ltd China
 
J89-0115765-3/1/13 14-Aug-2012 66VBY99 3004326829 Dabur India Limited India
 
J89-0115765-3/1/25 14-Aug-2012 66VBY99 3009085106 Ramkrisha Vidyut Ayurvedic Pharmacy, Pune India
 
MD8-1035128-6/1/1 28-Aug-2012 66VBY99 3009675679 Meiji Seika Kaisha Ltd. Taipei Taiwan
 
112-8368692-6/1/2 15-Aug-2012 66VCA99 3002948883 Aesica Pharmaceuticals GmbH Germany
 
112-8368692-6/1/1 15-Aug-2012 66VCA99 3003691504 Schwarz Biosciences Germany
 
D68-0135538-2/7/1 22-Aug-2012 66VCA99 3004001932 Life Rising(Tianjin)Natural Product R&D Center.,LTD. China
 
112-8720250-6/1/1 27-Aug-2012 66VCB99 3009664892 Moller & Ruiz Consultores Sc Mexico
 
UPS-7244069-2/1/1 15-Aug-2012 66VCC99 3007584468 Shanghai Dnd Pharma-Technology Co.,Inc China
 
UPS-7368100-5/1/1 16-Aug-2012 66VCC99 3009678900 Andre Clark Canada
 
112-8364870-2/1/1 15-Aug-2012 66VCL99 3008855266 Shree Marwal Sevashram India
 
112-8617884-8/1/1 02-Aug-2012 66VCP99 3008855266 Shree Marwal Sevashram India
 
AGT-0008360-1/14/1 03-Aug-2012 66VCS99 1000638096 Fj Arpino Ltd United Kingdom
 
UPS-6902234-7/1/1 10-Aug-2012 66VCS99 3005448362 Pharmacy Int.Gmbh Germany
 
GEO-8500047-5/1/1 10-Aug-2012 66VCY99 1000132620 Holland America Line - United States
 
112-8531088-9/3/1 15-Aug-2012 66VCY99 1000275495 Shirley Chemical Corporation Taiwan
 
112-8531088-9/5/1 15-Aug-2012 66VCY99 3009644791 Ksa Saudi Arabia
 
112-8472628-3/1/1 15-Aug-2012 66VCY99 3009638077 Oro Gold United Kingdom
 
112-8472628-3/1/3 15-Aug-2012 66VCY99 3009638077 Oro Gold United Kingdom
 
XXX-0242860-6/1/9 27-Aug-2012 66VCY99 3005088016 Godecke Gmbh Germany
 
UPS-7428771-1/1/2 29-Aug-2012 66VCY99 3009686845 Medicine Shoppe #185 Canada
 
UPS-7428771-1/1/1 29-Aug-2012 66VCY99 3009686845 Medicine Shoppe #185 Canada
 
UPS-7428771-1/1/3 29-Aug-2012 66VCY99 3009686845 Medicine Shoppe #185 Canada
 
XXX-0242924-0/1/10 29-Aug-2012 66VCY99 3005526145 Laboratorios Menarini, S.A. Italy
 
112-8526911-9/6/1/D 31-Aug-2012 66VCY99 1000225419 Make up Art Cosmetics Limited Canada
 
AEK-0396129-5/1/1/C 10-Aug-2012 66VDL99 3003338899 Perfector Skincare Ltd./Arasys Ltd. United Kingdom
 
AV3-0024708-5/1/2/A 01-Aug-2012 66VDY99 3005474564 Dermalogica Inc United States
 
AV3-0024708-5/1/2/B 01-Aug-2012 66VDY99 3005474564 Dermalogica Inc United States
 
AV3-0024708-5/1/2/C 01-Aug-2012 66VDY99 3005474564 Dermalogica Inc United States
 
T94-0057663-1/1/1 01-Aug-2012 66VDY99 2000033242 Jebsen & Jessen (GmbH & Co.)KG Germany
 
BJY-0710335-9/2/2 03-Aug-2012 66VDY99 3009670418 Degasa Sa De Cv Mexico
 
BJY-0710335-9/2/3 03-Aug-2012 66VDY99 3009670418 Degasa Sa De Cv Mexico
 
BJY-0710335-9/2/1 03-Aug-2012 66VDY99 3009670418 Degasa Sa De Cv Mexico
 
R12-0044749-7/14/1 06-Aug-2012 66VDY99 1000447151 Biotherm France
 
R12-0044870-1/6/1 06-Aug-2012 66VDY99 1000425663 Parfums Christian Dior Rachel Biotez France
 
R12-0044870-1/9/1 06-Aug-2012 66VDY99 1000425663 Parfums Christian Dior Rachel Biotez France
 
R12-0044870-1/22/1 06-Aug-2012 66VDY99 1000425663 Parfums Christian Dior Rachel Biotez France
 
HG8-0137585-5/1/1/B 06-Aug-2012 66VDY99 3009603219 GLOBAFARM LTDA. Brazil
 
HG8-0137585-5/1/1/C 06-Aug-2012 66VDY99 3008484202 Denova Pharmaceutical Ltda. Colombia
 
XXX-0289024-3/1/1 06-Aug-2012 66VDY99 3002808063 Bayer Pharma AG Germany
 
E84-0075159-8/3/1 10-Aug-2012 66VDY99 3009526643 Farmacia Drogueria San Jorge Ltda Colombia
 
XXX-0289719-8/1/3 10-Aug-2012 66VDY99 3003579793 Laboratorios Vijosa S.A de C.V. El Salvador
 
XXX-0289769-3/1/1 13-Aug-2012 66VDY99 3005325017 La Sante Colombia
 
XXX-0289769-3/1/2 13-Aug-2012 66VDY99 3006475565 Genfar Colombia
 
XXX-0242234-4/1/2 17-Aug-2012 66VDY99 1417322 Lang Dental Mfg Co, Inc. United States
 
101-9787404-2/18/1 21-Aug-2012 66VDY99 3004975024 John Masters Organics Hair Care United States
 
AEK-0283111-9/1/2/B 24-Aug-2012 66VDY99 3008085497 Jencare Skin Farm Jamaica
 
AEK-0283111-9/1/2/C 24-Aug-2012 66VDY99 3008085497 Jencare Skin Farm Jamaica
 
AEK-0283111-9/1/2/E 24-Aug-2012 66VDY99 3008085497 Jencare Skin Farm Jamaica
 
XXX-0178667-3/3/1 24-Aug-2012 66VDY99 3009451029 Industria Quimico Farmaceutica Guatemalteca S.A. Guatemala
 
XXX-0178667-3/3/2 24-Aug-2012 66VDY99 3009451029 Industria Quimico Farmaceutica Guatemalteca S.A. Guatemala
 
XXX-0242789-7/1/1 27-Aug-2012 66VDY99 3006347951 Merck Sa De Cv Mexico
 
XXX-0242860-6/1/4 27-Aug-2012 66VDY99 3006669838 Roemmers S.A. Uruguay
 
AMS-0002433-0/82/1 29-Aug-2012 66VDY99 3000243864 Clarins France
 
AMS-0002433-0/120/1 29-Aug-2012 66VDY99 3000243864 Clarins France
 
XXX-0242924-0/1/1 29-Aug-2012 66VDY99 3006347951 Merck Sa De Cv Mexico
 
XXX-0242924-0/1/7 29-Aug-2012 66VDY99 3005414380 Laboratorios Karnel S. de R. L. Honduras
 
XXX-0243010-7/1/7 29-Aug-2012 66VDY99 3003579793 Laboratorios Vijosa S.A de C.V. El Salvador
 
XXX-0243010-7/1/24 29-Aug-2012 66VDY99 3006669838 Roemmers S.A. Uruguay
 
XXX-0243010-7/1/26 29-Aug-2012 66VDY99 3005439651 Laboratorios Bussie S.A. Colombia
 
XXX-0243010-7/1/27 29-Aug-2012 66VDY99 3005439651 Laboratorios Bussie S.A. Colombia
 
XXX-0243010-7/1/28 29-Aug-2012 66VDY99 3006347951 Merck Sa De Cv Mexico
 
XXX-0243010-7/1/35 29-Aug-2012 66VDY99 3006347951 Merck Sa De Cv Mexico
 
AEK-0283388-3/1/2 30-Aug-2012 66VDY99 3009021883 Inverpal Eu Colombia
 
E7E-1027463-2/2/8 31-Aug-2012 66VDY99 3008878813 SESDERMA SL Spain
 
E7E-1027463-2/2/9/A 31-Aug-2012 66VDY99 3008878813 SESDERMA SL Spain
 
E7E-1027463-2/2/9/C 31-Aug-2012 66VDY99 3008878813 SESDERMA SL Spain
 
E7E-1027463-2/3/1/A 31-Aug-2012 66VDY99 3008878813 SESDERMA SL Spain
 
E7E-1027463-2/3/1/B 31-Aug-2012 66VDY99 3008878813 SESDERMA SL Spain
 
E7E-1027463-2/3/19 31-Aug-2012 66VDY99 3008878813 SESDERMA SL Spain
 
E7E-1027463-2/3/30 31-Aug-2012 66VDY99 3008878813 SESDERMA SL Spain
 
E7E-1027463-2/3/45 31-Aug-2012 66VDY99 3008878813 SESDERMA SL Spain
 
112-8121439-0/1/1 15-Aug-2012 66VIA99 3009600584 Manuel Aguirre Mexico
 
112-8533532-4/1/1 09-Aug-2012 66VIH99 3007569887 Ardea Biosciences United States
 
112-8533532-4/1/2 09-Aug-2012 66VIH99 3007569887 Ardea Biosciences United States
 
112-8392899-7/1/1/C 03-Aug-2012 66VIK99 3004588463 Laboratorios Grossman, S.A. Mexico
 
112-8471739-9/1/1 09-Aug-2012 66VIZ99 3006670601 Changzhou Meiang international Trade Co.,Ltd China
 
AYG-1002653-7/221/1 14-Aug-2012 66VLY99 3009537385 Kore Koncepts India
 
AYG-1002653-7/222/1 14-Aug-2012 66VLY99 3009537385 Kore Koncepts India
 
AYG-1002653-7/303/1 14-Aug-2012 66VLY99 3009537385 Kore Koncepts India
 
UPS-7152969-3/1/1 13-Aug-2012 66VOY99 3009472286 Pegasus Horse Supplements Ltd United Kingdom
 
112-8445935-6/1/2 15-Aug-2012 66YBJ99 3009565599 Siddhi Vinayak Herbals India
 
EUV-0001646-1/3/3 01-Aug-2012 66YBL99 3007817119 Atractiva Dominicana Dominican Republic
 
112-8445935-6/1/1 15-Aug-2012 66YBL99 3009565599 Siddhi Vinayak Herbals India
 
EUV-0001646-1/2/1 01-Aug-2012 66YBO99 3000596547 Laboratorios Lufra Farmacos S.A. Dominican Republic
 
EUV-0001646-1/2/2 01-Aug-2012 66YBY99 3000596547 Laboratorios Lufra Farmacos S.A. Dominican Republic
 
J34-0067373-0/3/2 14-Aug-2012 66YBY99 3004278205 Yeung Kong Foods Co Hong Kong SAR
 
D99-1025412-4/1/2 14-Aug-2012 66YBY99 3009614077 Pam Pharmaceutical India
 
D99-1025412-4/1/5 14-Aug-2012 66YBY99 3009614077 Pam Pharmaceutical India
 
D99-1025412-4/1/6 14-Aug-2012 66YBY99 3009614077 Pam Pharmaceutical India
 
D99-1025412-4/1/7 14-Aug-2012 66YBY99 3009614077 Pam Pharmaceutical India
 
D99-1025412-4/1/10 14-Aug-2012 66YBY99 3004290879 BAPS Swaminarayan Herbal Care India
 
D99-1025412-4/1/15 14-Aug-2012 66YBY99 3004290879 BAPS Swaminarayan Herbal Care India
 
D99-1025412-4/1/17 14-Aug-2012 66YBY99 3004290879 BAPS Swaminarayan Herbal Care India
 
D99-1025412-4/1/18 14-Aug-2012 66YBY99 3004290879 BAPS Swaminarayan Herbal Care India
 
D99-1025412-4/1/19 14-Aug-2012 66YBY99 3004290879 BAPS Swaminarayan Herbal Care India
 
D99-1025412-4/1/23 14-Aug-2012 66YBY99 3004290879 BAPS Swaminarayan Herbal Care India
 
D99-1025412-4/1/24 14-Aug-2012 66YBY99 3004290879 BAPS Swaminarayan Herbal Care India
 
D99-1025412-4/1/25 14-Aug-2012 66YBY99 3004290879 BAPS Swaminarayan Herbal Care India
 
D99-1025412-4/1/27 14-Aug-2012 66YBY99 3004290879 BAPS Swaminarayan Herbal Care India
 
D99-1025412-4/6/2 14-Aug-2012 66YBY99 3004290879 BAPS Swaminarayan Herbal Care India
 
D99-1025412-4/9/1 14-Aug-2012 66YBY99 3004290879 BAPS Swaminarayan Herbal Care India
 
BUP-2528991-2/1/1 27-Aug-2012 66YIY99 3002807336 Janssen Pharmaceutica, N.V. Belgium
 
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