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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 62-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-2122864-1/1/1 23-Aug-2011 62CCA16 3004797247 Transo-Pharm Handels-GmbH Germany
 
112-6014167-0/1/1 05-Aug-2011 62CCB99 3004786430 Sanofi Aventis France
 
112-7443354-3/1/2 19-Aug-2011 62CCC10 3003517605 Unichem Laboratories India
 
BJV-0242016-5/11/11 10-Aug-2011 62FAK34 1220701 Aplicare, Inc. United States
 
BJV-0242016-5/13/1 10-Aug-2011 62FAK34 1220701 Aplicare, Inc. United States
 
BJV-0241818-5/15/1 10-Aug-2011 62FAL23 1220701 Aplicare, Inc. United States
 
BJV-0241774-0/39/1 10-Aug-2011 62FAL34 1120159 Aplicare Incorporated United States
 
BJV-0241774-0/40/2 10-Aug-2011 62FAL34 1120159 Aplicare Incorporated United States
 
BJV-0241774-0/65/3 10-Aug-2011 62FAL34 2411192 Professional Disposables International, Inc. United States
 
BJV-0242016-5/30/1 10-Aug-2011 62FAL34 1120159 Aplicare Incorporated United States
 
BJV-0241818-5/19/1 10-Aug-2011 62FBK20 1484185 3M Company United States
 
BJV-0241818-5/19/2 10-Aug-2011 62FBK20 1484185 3M Company United States
 
BJV-0242016-5/34/1 10-Aug-2011 62FBK20 1484185 3M Company United States
 
BJV-0242156-9/3/1 10-Aug-2011 62FBK20 1484185 3M Company United States
 
BJV-0242577-6/7/1 10-Aug-2011 62FBK20 1484185 3M Company United States
 
BJV-0242577-6/7/2 10-Aug-2011 62FBK20 1484185 3M Company United States
 
BJV-0242577-6/7/3 10-Aug-2011 62FBK20 1484185 3M Company United States
 
BJV-0242255-9/13/1 10-Aug-2011 62FBL08 2411192 Professional Disposables International, Inc. United States
 
940-0175111-7/1/16 10-Aug-2011 62FBL20 3004207724 Farm Invest Ukraine
 
940-0175111-7/1/22 10-Aug-2011 62FBL20 3004207724 Farm Invest Ukraine
 
940-0175111-7/1/25 10-Aug-2011 62FBL20 3004207724 Farm Invest Ukraine
 
MR5-0049213-4/1/1 23-Aug-2011 62FCS08 3002806711 Cadila Pharmaceuticals Limited India
 
224-4222734-8/1/9 11-Aug-2011 62GAL99 3006142341 Kerala Ayurveda Pharmacy Ltd India
 
224-4222734-8/1/10 11-Aug-2011 62GAL99 3006142341 Kerala Ayurveda Pharmacy Ltd India
 
224-4222734-8/1/12 11-Aug-2011 62GAL99 3006142341 Kerala Ayurveda Pharmacy Ltd India
 
AEK-8379516-7/2/1 15-Aug-2011 62GBO92 3009008276 Murali Medicals India
 
112-0901829-5/1/1 24-Aug-2011 62GCA99 3007507927 Genomma Laboratories Mexico
 
112-7933912-5/1/4 05-Aug-2011 62GCB46 3007102377 Fresenius Medical Care de Mexico Mexico
 
112-8933996-5/1/1 19-Aug-2011 62GCB94 3007823194 Laboratorio Invermed Venezuela
 
112-5960989-3/1/1 19-Aug-2011 62GCB99 3002807747 Novartis Farma S.P.A. Italy
 
UPS-3114077-1/2/1 15-Aug-2011 62GCE18 3009041016 Claudia Garcia Velez Colombia
 
112-2215872-2/1/2 24-Aug-2011 62GCE42 3004105434 Laboratorios Quimica son's, S.A. de C.V. Mexico
 
BJV-0241774-0/7/3 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC United States
 
BJV-0241774-0/7/5 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC United States
 
BJV-0241774-0/7/7 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC United States
 
BJV-0241774-0/7/8 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC United States
 
BJV-0241818-5/12/1 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC United States
 
BJV-0241818-5/13/3 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC United States
 
BJV-0241818-5/31/1 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC United States
 
BJV-0242016-5/4/5 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC United States
 
BJV-0242016-5/4/6 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC United States
 
BJV-0242016-5/4/7 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC United States
 
BJV-0242016-5/13/2 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC United States
 
BJV-0242016-5/13/3 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC United States
 
BJV-0242156-9/10/1 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC United States
 
BJV-0242255-9/4/2 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC United States
 
BJV-0242255-9/6/3 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC United States
 
BJV-0242577-6/11/1 10-Aug-2011 62HBL99 3004932373 CareFusion 213, LLC United States
 
663-0836991-8/1/1 24-Aug-2011 62HCZ99 3001174929 Hospira Australia Pty Ltd. Australia
 
112-0217146-3/1/1 24-Aug-2011 62HSY02 3008498699 Hangzhou Dayangchem Co Ltd China
 
112-2328284-4/1/1 23-Aug-2011 62ICY24 3006477134 Shanghai Multi-med Union Co., Ltd China
 
112-9710601-9/1/1 26-Aug-2011 62IQA99 3003563645 Catalent Pharma Solutions, LLC United States
 
112-9710601-9/1/2 26-Aug-2011 62IQA99 3003563645 Catalent Pharma Solutions, LLC United States
 
M21-0744295-8/1/1 25-Aug-2011 62LAA99 3006094247 Research Pharmaceutical Co Ltd China
 
112-8237496-0/1/1 05-Aug-2011 62LCA47 3008452113 Laboratorios Servet, Sa De Cv Mexico
 
112-2638194-0/1/1 23-Aug-2011 62LDA44 3008193661 Glaxosmithkline Uk Limited United Kingdom
 
FY6-2008067-8/12/1 24-Aug-2011 62MAJ08 3004135577 Novartis United States
 
940-0175111-7/1/30 10-Aug-2011 62MBJ08 3004207724 Farm Invest Ukraine
 
112-2447997-7/1/1 24-Aug-2011 62MBY01 3008939151 Gui Lin Tian He Yao Ye Coldt China
 
112-2779624-5/1/1 19-Aug-2011 62NCC99 3001401009 Biogen Gmbh Germany
 
112-2779624-5/1/2 19-Aug-2011 62NCC99 3001401009 Biogen Gmbh Germany
 
112-1381865-6/3/2 24-Aug-2011 62OCA09 3003056667 Boehringer Ingelheim Vetmedica Sa D Mexico
 
UPS-2896064-5/3/1 01-Aug-2011 62OCA41 3009014872 Olga Lucia Lemos Colombia
 
112-7933912-5/1/1 05-Aug-2011 62OCB41 3004776165 Laboratorios Kendrick Mexico
 
112-8052126-5/2/1 05-Aug-2011 62OCB43 3004819820 Lupin Limited India
 
112-7933912-5/1/2 05-Aug-2011 62OCB47 1000549797 Merck Mexico, S.A. Mexico
 
112-0854493-7/1/1 24-Aug-2011 62OCE49 3008770849 Stutz Fama Farmacia Brazil
 
201-9389192-5/1/1 08-Aug-2011 62OCS22 3004086884 Aurobindo Pharma Limited India
 
112-7933912-5/1/3 05-Aug-2011 62ODB14 3004534358 Laboratorios Diba, S.A. Mexico
 
224-4222734-8/1/1 11-Aug-2011 62QBL99 3006142341 Kerala Ayurveda Pharmacy Ltd India
 
224-4222734-8/1/3 11-Aug-2011 62QBL99 3006142341 Kerala Ayurveda Pharmacy Ltd India
 
224-4222734-8/1/6 11-Aug-2011 62QBL99 3006142341 Kerala Ayurveda Pharmacy Ltd India
 
224-4222734-8/1/7 11-Aug-2011 62QBL99 3006142341 Kerala Ayurveda Pharmacy Ltd India
 
112-2215872-2/1/3 24-Aug-2011 62QCB07 1000400803 Productos Farm. Collins, Sa De Cv Mexico
 
UPS-3082188-4/1/1 19-Aug-2011 62TCY06 3005401518 Astra Zeneca Italy
 
442-3100741-8/25/1 19-Aug-2011 62UBY99 3008806723 Hamdard Maullaham (Doasta) India
 
UPS-2915912-2/1/1/A 02-Aug-2011 62VAE99 3009013289 Allicin International Limited United Kingdom
 
UPS-2915912-2/1/1/B 02-Aug-2011 62VAE99 3009013289 Allicin International Limited United Kingdom
 
112-2864911-2/2/1 23-Aug-2011 62VCB15 1000523075 Gilead Sciences, Inc. United States
 
112-2864911-2/1/1 23-Aug-2011 62VCB32 3008990261 Av Ing Hergo Argentina
 
112-5579556-3/1/1 05-Aug-2011 62VIA99 3004786430 Sanofi Aventis France
 
112-5383646-8/1/1 05-Aug-2011 62VIS99 3006031727 Alexion Pharmaceuticals, Inc. United States
 
112-3407552-6/10/1 29-Aug-2011 62WBY17 3002806448 Beiersdorf AG Germany
 
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