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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
110-2335697-9/1/1/B 15-Dec-2005 66BAY99 3004136252 Herbal Life And Essence Co. Canada
 
112-8093750-8/1/1 16-Dec-2005 66FPA99 3001229217 Zuellig Pharma Corporation Philippines
 
XXX-0135404-3/1/3 27-Dec-2005 66JCA02 3005447834 Farmacia Kimtemen Ecuador
 
XXX-0135404-3/1/5 27-Dec-2005 66JCA99 3005447834 Farmacia Kimtemen Ecuador
 
112-8288399-9/1/1 19-Dec-2005 66KDC99 3005449801 Glaxowellcome (New Zealand) Ltd New Zealand
 
112-8567664-8/1/1 14-Dec-2005 66MCA75 3005481035 Ciba Spezialitaeten Chemie Switzerland
 
AEK-7075267-6/1/1 12-Dec-2005 66MCB60 3005418438 Ketan B Patel India
 
AEK-7075267-6/1/5 12-Dec-2005 66MCB60 3005418438 Ketan B Patel India
 
AEK-7075267-6/1/4 12-Dec-2005 66MCB60 3005418438 Ketan B Patel India
 
AEK-7075267-6/1/3 12-Dec-2005 66MCB60 3005418438 Ketan B Patel India
 
AEK-7075267-6/1/2 12-Dec-2005 66MCB60 3005418438 Ketan B Patel India
 
AEK-7075267-6/1/6 12-Dec-2005 66MCB60 3005418438 Ketan B Patel India
 
112-8787995-1/1/12 12-Dec-2005 66MCB86 3005377755 Alphapharma Netherlands
 
112-8787995-1/1/16 12-Dec-2005 66MCB91 3005377755 Alphapharma Netherlands
 
112-8787995-1/1/17 12-Dec-2005 66MCB91 3005377755 Alphapharma Netherlands
 
KL1-0125122-3/2/1 08-Dec-2005 66PAJ99 3001940048 Kamel Azar & Sons Co. Jordan
 
310-9548168-0/54/1 28-Dec-2005 66PBJ07 3004541688 Blistex Ltd Canada
 
110-2353305-6/3/1 09-Dec-2005 66PBJ99 1000131765 Nam Yang Company Korea, Republic Of (South)
 
112-8429326-2/1/1 15-Dec-2005 66PBJ99 3005460139 Farmacia Espina Spain
 
112-8383984-2/1/1/A 15-Dec-2005 66PBJ99 3005440513 Vivier Pharma Inc Canada
 
WRE-0333302-8/1/2 07-Dec-2005 66PBR99 1000329468 Hankook Cosmetics Ind. Co., Ltd. Korea, Republic Of (South)
 
WRE-0333302-8/1/3 07-Dec-2005 66PBR99 1000329468 Hankook Cosmetics Ind. Co., Ltd. Korea, Republic Of (South)
 
WRE-0333302-8/1/4 07-Dec-2005 66PBR99 1000329468 Hankook Cosmetics Ind. Co., Ltd. Korea, Republic Of (South)
 
WRE-0333302-8/1/5 07-Dec-2005 66PBR99 1000329468 Hankook Cosmetics Ind. Co., Ltd. Korea, Republic Of (South)
 
WRE-0333302-8/1/6 07-Dec-2005 66PBR99 1000329468 Hankook Cosmetics Ind. Co., Ltd. Korea, Republic Of (South)
 
WRE-0333302-8/1/1 07-Dec-2005 66PDR99 1000329468 Hankook Cosmetics Ind. Co., Ltd. Korea, Republic Of (South)
 
112-8425537-8/1/1 07-Dec-2005 66SCA99 3004556125 Astrazenca Uk Ltd United Kingdom
 
XXX-0135521-4/1/1/A 28-Dec-2005 66SCC05 3005448911 Galeno Quimica C.A. Venezuela
 
FG1-2106504-8/2/1 05-Dec-2005 66V99 3001930375 PRODUCTOS CAPILARES L'OREAL S.A. Spain
 
112-8120212-6/1/1 10-Dec-2005 66VAC99 3004554927 Ucb Pharma Spa Italy
 
AYG-1000687-7/35/1 27-Dec-2005 66VAL99 3004455408 Marico Industries Pvt Ltd India
 
AEK-7076406-9/1/1 29-Dec-2005 66VAR99 3005428897 Mrs Rohini Lintotawela Sri Lanka
 
KL1-0125122-3/1/1 08-Dec-2005 66VAU99 3001940048 Kamel Azar & Sons Co. Jordan
 
112-7948883-6/1/1/C 10-Dec-2005 66VAY99 3005398592 Giuseppa Capitani Italy
 
110-2335697-9/1/1/A 15-Dec-2005 66VAY99 3004136252 Herbal Life And Essence Co. Canada
 
AYG-1000674-5/26/1 27-Dec-2005 66VAY99 3005387466 Ttk Pharma Ltd India
 
AEK-7598524-8/1/1 29-Dec-2005 66VAY99 3003664948 Prime Herbal Health Care India
 
AYG-1000670-3/5/1 30-Dec-2005 66VBC99 3004259394 The Himalaya Drug Company India
 
906-0641687-4/1/1 27-Dec-2005 66VBE99 1719962 ProPac Laboratories, Inc. United States
 
110-2859565-4/1/1 12-Dec-2005 66VBJ99 3004504829 Julphar Gulf Pharmaceutical Industries United Arab Emirates
 
AYG-1000687-7/41/1 27-Dec-2005 66VBJ99 3005353381 Warrier'S Panchakarma Center India
 
965-0116510-2/2/1 05-Dec-2005 66VBL99 3003208006 Nattura Laboratorios Sa De Cv Mexico
 
K80-0913124-5/1/1 12-Dec-2005 66VBL99 3004333114 Jilin Longyuan Health Food Co. Ltd. China
 
112-8229408-0/1/1 14-Dec-2005 66VBL99 3003621726 Magic Dragon Mist Canada
 
XXX-0135014-0/1/3 28-Dec-2005 66VBP99 3004641553 Merck, S.A. de C.V. Mexico
 
XXX-0135014-0/1/4 28-Dec-2005 66VBP99 1000549797 Merck Mexico, S.A. Mexico
 
BDN-0008060-1/1/1 21-Dec-2005 66VBR99 3005126520 Trade Avail South Africa
 
WIB-1194203-7/1/1 21-Dec-2005 66VBR99 3004985603 han kook shin yak pharmaceutical co,ltd Korea, Republic Of (South)
 
GM4-0554186-8/1/1 21-Dec-2005 66VBR99 3005417721 Bali Herbals Indonesia
 
GM4-0554186-8/1/2 21-Dec-2005 66VBR99 3005417721 Bali Herbals Indonesia
 
AEK-7076443-2/1/1 13-Dec-2005 66VBS99 3005429557 Ibn Al Bitar Est United Arab Emirates
 
WRE-0333302-8/2/9 07-Dec-2005 66VBY99 1000329468 Hankook Cosmetics Ind. Co., Ltd. Korea, Republic Of (South)
 
U29-0174274-4/1/1 21-Dec-2005 66VBY99 3005308588 China Tea & Herbal World Honk Kong Co Hong Kong SAR
 
U29-0174274-4/2/1 21-Dec-2005 66VBY99 3005308588 China Tea & Herbal World Honk Kong Co Hong Kong SAR
 
U29-0174274-4/3/1 21-Dec-2005 66VBY99 3005308588 China Tea & Herbal World Honk Kong Co Hong Kong SAR
 
U29-0174274-4/4/1 21-Dec-2005 66VBY99 3005308588 China Tea & Herbal World Honk Kong Co Hong Kong SAR
 
AYG-1000687-7/39/1 27-Dec-2005 66VBY99 3005353382 Wonder Products India
 
880-0054600-7/1/1 27-Dec-2005 66VBY99 3002936531 Prep Int India
 
277-0108508-9/17/1 28-Dec-2005 66VBY99 3004503644 Smileprant Cosmetic Co.,Ltd. Thailand
 
277-0108508-9/19/1 28-Dec-2005 66VBY99 3003510107 Golden Cup Co.,Ltd. Thailand
 
110-2785265-0/1/2 07-Dec-2005 66VCA99 3005428319 Dr.Anrian Ariawan Indonesia
 
110-2785265-0/1/4 07-Dec-2005 66VCA99 1000304542 Roche Spa Italy
 
110-2967015-9/1/1 15-Dec-2005 66VCA99 3005303473 Pharmaroth Latin America Sa De Cv Mexico
 
110-2077713-6/1/1 15-Dec-2005 66VCA99 3005322660 Andrew Han Korea, Republic Of (South)
 
110-2928177-5/1/1 27-Dec-2005 66VCA99 3005457940 Ms Chuluuntsetseg Mongolia
 
110-2928177-5/1/2 27-Dec-2005 66VCA99 3005457940 Ms Chuluuntsetseg Mongolia
 
110-2928177-5/1/3 27-Dec-2005 66VCA99 3005457940 Ms Chuluuntsetseg Mongolia
 
110-2928177-5/1/7 27-Dec-2005 66VCA99 3005457940 Ms Chuluuntsetseg Mongolia
 
110-2928177-5/1/8 27-Dec-2005 66VCA99 3005457940 Ms Chuluuntsetseg Mongolia
 
110-2928177-5/1/6 27-Dec-2005 66VCA99 3005457940 Ms Chuluuntsetseg Mongolia
 
XXX-0135404-3/1/4 27-Dec-2005 66VCA99 3005447834 Farmacia Kimtemen Ecuador
 
112-8400645-8/2/1 07-Dec-2005 66VCB99 3005456691 Genfar Colombia
 
112-8546946-5/1/1 15-Dec-2005 66VCB99 3005478129 Eli Lilly Italia Spa Italy
 
N90-0533178-6/1/1 28-Dec-2005 66VCB99 3003833256 Dafra Pharma N.V. SA Belgium
 
N90-0533178-6/2/1 28-Dec-2005 66VCB99 3003833256 Dafra Pharma N.V. SA Belgium
 
110-2787762-4/1/3 05-Dec-2005 66VCK99 3000203232 Apothecure, Inc United States
 
110-2787762-4/1/4 05-Dec-2005 66VCK99 3000203232 Apothecure, Inc United States
 
110-2787762-4/1/6 05-Dec-2005 66VCK99 3000203232 Apothecure, Inc United States
 
110-2787762-4/1/8 05-Dec-2005 66VCK99 3000203232 Apothecure, Inc United States
 
110-2787762-4/1/9 05-Dec-2005 66VCK99 3000203232 Apothecure, Inc United States
 
110-2787762-4/1/10 05-Dec-2005 66VCK99 3000203232 Apothecure, Inc United States
 
110-2787762-4/1/11 05-Dec-2005 66VCK99 3000203232 Apothecure, Inc United States
 
110-2787762-4/1/12 05-Dec-2005 66VCK99 3000203232 Apothecure, Inc United States
 
110-2787762-4/1/13 05-Dec-2005 66VCK99 3000203232 Apothecure, Inc United States
 
110-2787762-4/1/14 05-Dec-2005 66VCK99 3000203232 Apothecure, Inc United States
 
110-2787762-4/1/15 05-Dec-2005 66VCK99 3000203232 Apothecure, Inc United States
 
110-2787762-4/1/16 05-Dec-2005 66VCK99 3000203232 Apothecure, Inc United States
 
110-2787762-4/1/17 05-Dec-2005 66VCK99 3000203232 Apothecure, Inc United States
 
110-2787762-4/1/18 05-Dec-2005 66VCK99 3000203232 Apothecure, Inc United States
 
110-2787762-4/1/19 05-Dec-2005 66VCK99 3000203232 Apothecure, Inc United States
 
110-3077970-0/1/1/A 28-Dec-2005 66VCL99 2000006429 SILVERHEALTH PRODUCTS INC Canada
 
112-8441818-2/1/1 09-Dec-2005 66VCP99 3005462130 Organic Resources Ltd United States
 
112-8701742-9/1/1 27-Dec-2005 66VCP99 3002806504 Biologische Heilmittel Heel Gmbh Germany
 
XXX-0135101-5/1/4 28-Dec-2005 66VCP99 3003143205 Aventis Pharma, S.A. De C.V Mexico
 
XXX-0135142-9/1/2 28-Dec-2005 66VCP99 3002806504 Biologische Heilmittel Heel Gmbh Germany
 
112-8338855-0/1/1 09-Dec-2005 66VCR99 3003323314 Cepham Milk Specialties Ltd. India
 
112-8852076-0/1/1 16-Dec-2005 66VCY99 3003766284 General Drug And Co.Inc. Philippines
 
XXX-0133010-0/1/3 06-Dec-2005 66VDB99 3003817578 Aventis Pharmaceuticals Inc Argentina
 
XXX-0135014-0/1/1 28-Dec-2005 66VDE99 3005355215 Laboratorios Lamfer Guatemala
 
XXX-0134407-7/1/3 13-Dec-2005 66VDF99 3005106103 Lab Spefar Venezuela
 
110-2787762-4/1/2 05-Dec-2005 66VDK99 3000203232 Apothecure, Inc United States
 
112-8424459-6/1/1 07-Dec-2005 66VDK99 3005459508 Bionational Ltd United Kingdom
 
XXX-0135008-2/1/2 28-Dec-2005 66VDK99 1000183111 BOEHRINGER INGELHEIM PROMECO S.A. DE C.V Mexico
 
XXX-0135489-4/1/4 27-Dec-2005 66VDP99 3003143205 Aventis Pharma, S.A. De C.V Mexico
 
XXX-0135235-1/1/1 28-Dec-2005 66VDP99 3003806623 Laboratorios Vizcaino S.A. Guatemala
 
XXX-0135101-5/1/1 28-Dec-2005 66VDP99 3003811155 Laboratorios Arsal El Salvador
 
AEK-7071981-6/1/1 02-Dec-2005 66VDY99 3003645093 Shree Baidyanath Ayurved Bhawan India
 
020-0311252-7/4/1/B 05-Dec-2005 66VDY99 3001429246 Dead Sea Premier Cosmetics Lab Israel
 
XXX-0132454-1/1/1 05-Dec-2005 66VDY99 3001027464 UNKNOWN Guatemala
 
XXX-0132454-1/1/2 05-Dec-2005 66VDY99 3001027464 UNKNOWN Guatemala
 
XXX-0132454-1/1/3 05-Dec-2005 66VDY99 3001027464 UNKNOWN Guatemala
 
XXX-0133342-7/1/1 05-Dec-2005 66VDY99 3003641053 Aventis Pharma SA Guatemala
 
XXX-0133342-7/1/2 05-Dec-2005 66VDY99 3005021708 Suipharma Guatemala
 
XXX-0133449-0/1/7 05-Dec-2005 66VDY99 3005416595 Laboratorios y Drogueria Nacional Guatemala
 
XXX-0134033-1/1/1 05-Dec-2005 66VDY99 3004328202 Grupo Consultor S.A. Peru
 
XXX-0134033-1/1/2 05-Dec-2005 66VDY99 3004328202 Grupo Consultor S.A. Peru
 
XXX-0134033-1/1/3 05-Dec-2005 66VDY99 3004328202 Grupo Consultor S.A. Peru
 
XXX-0134033-1/1/4 05-Dec-2005 66VDY99 3004328202 Grupo Consultor S.A. Peru
 
XXX-0134033-1/1/5 05-Dec-2005 66VDY99 3004328202 Grupo Consultor S.A. Peru
 
XXX-0134033-1/1/6 05-Dec-2005 66VDY99 3004328202 Grupo Consultor S.A. Peru
 
XXX-0134033-1/1/7 05-Dec-2005 66VDY99 3004328202 Grupo Consultor S.A. Peru
 
XXX-0134033-1/1/8 05-Dec-2005 66VDY99 3004328202 Grupo Consultor S.A. Peru
 
XXX-0134033-1/1/9 05-Dec-2005 66VDY99 3004328202 Grupo Consultor S.A. Peru
 
XXX-0129671-5/1/9 06-Dec-2005 66VDY99 3001027464 UNKNOWN Guatemala
 
XXX-0129671-5/1/10 06-Dec-2005 66VDY99 3003641053 Aventis Pharma SA Guatemala
 
XXX-0129671-5/1/16 06-Dec-2005 66VDY99 3003724366 Glaxo Smith Kline Panama S.A. Panama
 
XXX-0134407-7/1/2 13-Dec-2005 66VDY99 3005430367 BADEN-BADEN Germany
 
XXX-0134413-5/1/3 13-Dec-2005 66VDY99 3005430754 Daewon Pharm Co., LTD Guatemala
 
880-0049516-3/7/1 27-Dec-2005 66VDY99 1000608298 P F C Inc Co Ltd Thailand
 
XXX-0135900-0/1/1 28-Dec-2005 66VDY99 3004901866 Pmn Suprimentos Ltda Brazil
 
XXX-0135902-6/1/1 28-Dec-2005 66VDY99 3004901866 Pmn Suprimentos Ltda Brazil
 
XXX-0135905-9/1/1 29-Dec-2005 66VDY99 3004901866 Pmn Suprimentos Ltda Brazil
 
112-8369647-3/1/1 02-Dec-2005 66VIP99 2210048 Merck, Inc. United States
 
112-8193901-6/1/1 10-Dec-2005 66VIP99 3002808376 Apotex, Inc. Canada
 
112-8521421-8/1/1 14-Dec-2005 66VIP99 1000124057 Novartis Vaccine and Diagnostics, Inc. United States
 
AEG-2001734-0/12/1 05-Dec-2005 66VIR99 3004692895 Nestle Mexico, S.A. de C.V. Mexico
 
AEG-2001734-0/12/2 05-Dec-2005 66VIR99 3004692895 Nestle Mexico, S.A. de C.V. Mexico
 
AEG-2001734-0/12/3 05-Dec-2005 66VIR99 3004692895 Nestle Mexico, S.A. de C.V. Mexico
 
880-0053889-7/11/1 27-Dec-2005 66VL99 3003174807 Sara Lee Philippines Inc. Philippines
 
DZ1-3036382-0/1/13 21-Dec-2005 66YAR99 3004264114 Shaanxi Jiahe Phytochem Co., Ltd. China
 
DO7-0100204-3/1/1 21-Dec-2005 66YCA99 3001187973 Pt Primasindo Medikamas Pharmaceuticals Indonesia
 
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