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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
UPS-1054534-7/1/1 24-Feb-2011 66BAS44 3007676948 Shenzhen Shen Kelong Ltd China
 
AYG-1002263-5/130/1 27-Feb-2011 66BBJ99 3008641268 Fem Care Pharma India
 
AEK-8520241-0/1/1 01-Feb-2011 66BBL44 3008571438 Healthy Shisha Lebanon
 
112-5515976-0/1/2 23-Feb-2011 66FDB05 3002706162 Odan Laboratories Ltd Canada
 
AEK-8635127-3/1/1 23-Feb-2011 66MCA99 3008741873 Md Ishthaqur Rahman Bangladesh
 
112-8803661-2/1/1 23-Feb-2011 66NCA06 3003794869 Bristol-Myers Squibb Company South Africa
 
GQ9-1003363-4/5/1 14-Feb-2011 66PBJ99 3004008582 Schweizer-Effax Gmbh Germany
 
UPS-1291908-6/6/1 23-Feb-2011 66PBL99 3008775755 Yangzhou Oland Group Limited China
 
112-9617315-9/1/1 23-Feb-2011 66SCB27 3001443914 Bayer Inc Canada
 
112-0701882-6/4/1 25-Feb-2011 66SCB49 3002906944 Apotex Inc. Canada
 
H87-0185991-5/3/1 08-Feb-2011 66V99 3002779991 Distribudora de Alimentos Naturales y Nutricionales Mexico
 
960-0193744-8/1/1/A 02-Feb-2011 66VAL99 3003579793 Laboratorios Vijosa S.A de C.V. El Salvador
 
960-0193744-8/1/1/B 02-Feb-2011 66VAL99 3003579793 Laboratorios Vijosa S.A de C.V. El Salvador
 
960-0193744-8/1/2 02-Feb-2011 66VAL99 3004816976 Enmilen, S.A. de C.V. El Salvador
 
334-4748332-3/2/6 09-Feb-2011 66VAY99 3005808407 Boiron France
 
XXX-0271669-5/1/2 22-Feb-2011 66VAY99 3006127003 Caplin Point Laboratories India
 
UPS-0034298-6/1/1 01-Feb-2011 66VBB99 3007225366 Herbal Technologies Bv Netherlands
 
112-5923653-1/1/1 07-Feb-2011 66VBB99 3008167676 Hainan Resurgence Natural Health China
 
UPS-0034298-6/2/1 01-Feb-2011 66VBJ99 3007225366 Herbal Technologies Bv Netherlands
 
UPS-0034298-6/2/3 01-Feb-2011 66VBJ99 3007225366 Herbal Technologies Bv Netherlands
 
960-0193744-8/2/1 02-Feb-2011 66VBL99 3010221253 LABORATORIOS LOPEZ, S.A DE C.V. El Salvador
 
554-9398069-6/1/1 11-Feb-2011 66VBL99 3004697958 Biokemical, S.A. de C.V El Salvador
 
UPS-1156197-0/2/1/D 23-Feb-2011 66VBL99 1000461486 Lendan Cosmetica Tecnica Spain
 
UPS-1156197-0/2/1/S 23-Feb-2011 66VBL99 1000461486 Lendan Cosmetica Tecnica Spain
 
UPS-1156197-0/2/1/R 23-Feb-2011 66VBL99 1000461486 Lendan Cosmetica Tecnica Spain
 
UPS-1156197-0/2/1/E 23-Feb-2011 66VBL99 1000461486 Lendan Cosmetica Tecnica Spain
 
AEK-8602747-7/1/1 25-Feb-2011 66VBS99 3002785393 Roche Switzerland
 
XXX-0270368-5/1/3 07-Feb-2011 66VBY99 3005200425 Mediproducts Guatemala
 
334-4748332-3/2/14 09-Feb-2011 66VBY99 3005808407 Boiron France
 
AEK-8365097-4/1/1 03-Feb-2011 66VCA99 3008695652 Dr Adam Kraklewicz Germany
 
112-9639744-4/1/1 23-Feb-2011 66VCB99 3007921295 Remedia Homoeopath Austria
 
UPS-0902315-7/1/1 03-Feb-2011 66VCS99 3008716473 Tv 2 As Norway
 
XXX-0270393-3/1/1 07-Feb-2011 66VCS99 3003831450 Infarma Honduras
 
MA7-0633338-6/3/1 10-Feb-2011 66VCS99 3008399763 Veld'S Hoche Freidland France
 
AEK-8366814-1/1/2 18-Feb-2011 66VDA99 3008733704 Rakesh Kumar India
 
112-9606930-8/1/1 23-Feb-2011 66VDA99 3007921295 Remedia Homoeopath Austria
 
112-9606930-8/1/2 23-Feb-2011 66VDA99 3007921295 Remedia Homoeopath Austria
 
112-9582644-3/1/1 23-Feb-2011 66VDA99 3007921295 Remedia Homoeopath Austria
 
112-6042177-5/1/1/B 23-Feb-2011 66VDB99 3008185865 Zorka Farma Bosnia-Hercegovina
 
J50-0119990-8/1/14 18-Feb-2011 66VDJ99 3008601545 Hui Yung Medicine Co., Ltd Taiwan
 
AEK-8366814-1/1/1 18-Feb-2011 66VDL99 3008733704 Rakesh Kumar India
 
UPS-1156197-0/2/1/J 23-Feb-2011 66VDL99 1000461486 Lendan Cosmetica Tecnica Spain
 
H87-0186115-0/1/1 23-Feb-2011 66VDR99 3006794691 RAMONA COSMACEUTICALS PRIVATE LIMITED India
 
H87-0186115-0/1/2 23-Feb-2011 66VDR99 3006794691 RAMONA COSMACEUTICALS PRIVATE LIMITED India
 
112-9605370-8/2/1 23-Feb-2011 66VDR99 3007921295 Remedia Homoeopath Austria
 
112-9605370-8/1/1 23-Feb-2011 66VDR99 3007921295 Remedia Homoeopath Austria
 
XXX-0270393-3/1/2 07-Feb-2011 66VDY99 3007564373 Chalver Laboratorios Colombia
 
XXX-0270368-5/1/1 07-Feb-2011 66VDY99 3002806906 Merck KGaA Germany
 
XXX-0270368-5/1/2 07-Feb-2011 66VDY99 3006347951 Merck Sa De Cv Mexico
 
XXX-0271309-8/1/1 07-Feb-2011 66VDY99 3005120268 Corporacion Donovan Werke Internacional Guatemala
 
XXX-0271309-8/1/2 07-Feb-2011 66VDY99 3008365514 North China Pharmaceutical Co Ltd China
 
XXX-0271324-7/1/22 14-Feb-2011 66VDY99 3003916517 Unipharma International, SA Guatemala
 
413-0025264-5/1/2 23-Feb-2011 66VDY99 3006788790 Diana Stalder Philippines
 
413-0025264-5/1/3 23-Feb-2011 66VDY99 3006788790 Diana Stalder Philippines
 
413-0025264-5/1/4 23-Feb-2011 66VDY99 3006788790 Diana Stalder Philippines
 
413-0025264-5/1/5 23-Feb-2011 66VDY99 3006788790 Diana Stalder Philippines
 
413-0025264-5/1/6 23-Feb-2011 66VDY99 3006788790 Diana Stalder Philippines
 
413-0025264-5/2/1 23-Feb-2011 66VDY99 3006788790 Diana Stalder Philippines
 
413-0025264-5/2/2 23-Feb-2011 66VDY99 3006788790 Diana Stalder Philippines
 
112-6131857-4/1/1 23-Feb-2011 66VIP99 3004459800 Glaxosmithkline Pharmaceuticals India
 
112-6131857-4/1/2 23-Feb-2011 66VIP99 3004459800 Glaxosmithkline Pharmaceuticals India
 
112-6131857-4/1/3 23-Feb-2011 66VIP99 3004459800 Glaxosmithkline Pharmaceuticals India
 
SG5-0425977-4/1/1 14-Feb-2011 66VIY99 3007928905 Norwich Pharmaceuticals United States
 
SG5-0425977-4/1/2 14-Feb-2011 66VIY99 3007928905 Norwich Pharmaceuticals United States
 
SG5-0425977-4/2/1 14-Feb-2011 66VIY99 1000432766 Hex Ag Germany
 
SG5-0425977-4/3/1 14-Feb-2011 66VIY99 3006707930 Polfa Ul Poland
 
SG5-0425977-4/4/1 14-Feb-2011 66VIY99 1000432766 Hex Ag Germany
 
SG5-0425977-4/7/1 14-Feb-2011 66VIY99 3007928905 Norwich Pharmaceuticals United States
 
SG5-0426056-6/3/1 14-Feb-2011 66VIY99 3007928905 Norwich Pharmaceuticals United States
 
SG5-0426056-6/4/1 14-Feb-2011 66VIY99 1000432766 Hex Ag Germany
 
SG5-0426056-6/5/1 14-Feb-2011 66VIY99 1000432766 Hex Ag Germany
 
SG5-0426056-6/6/1 14-Feb-2011 66VIY99 3006707930 Polfa Ul Poland
 
SG5-0426056-6/7/1 14-Feb-2011 66VIY99 3007928905 Norwich Pharmaceuticals United States
 
SG5-0426106-9/1/1 14-Feb-2011 66VIY99 3007928905 Norwich Pharmaceuticals United States
 
SG5-0426106-9/3/1 14-Feb-2011 66VIY99 3006707930 Polfa Ul Poland
 
SG5-0426106-9/4/1 14-Feb-2011 66VIY99 1000432766 Hex Ag Germany
 
SG5-0426106-9/5/1 14-Feb-2011 66VIY99 3007928905 Norwich Pharmaceuticals United States
 
SG5-0426106-9/6/1 14-Feb-2011 66VIY99 1000432766 Hex Ag Germany
 
SG5-0426147-3/1/1 14-Feb-2011 66VIY99 3000123645 Eli Lilly And Company United States
 
SG5-0426148-1/1/1 14-Feb-2011 66VIY99 3007928905 Norwich Pharmaceuticals United States
 
SG5-0426148-1/2/1 14-Feb-2011 66VIY99 3007928905 Norwich Pharmaceuticals United States
 
SG5-0426148-1/3/1 14-Feb-2011 66VIY99 3006707930 Polfa Ul Poland
 
SG5-0426148-1/4/1 14-Feb-2011 66VIY99 1000432766 Hex Ag Germany
 
SG5-0426095-4/2/1 14-Feb-2011 66VIY99 1000432766 Hex Ag Germany
 
SG5-0426095-4/3/1 14-Feb-2011 66VIY99 3006707930 Polfa Ul Poland
 
SG5-0426095-4/4/1 14-Feb-2011 66VIY99 3007928905 Norwich Pharmaceuticals United States
 
SG5-0426144-0/1/1 14-Feb-2011 66VIY99 3000123645 Eli Lilly And Company United States
 
SG5-0426175-4/3/1 14-Feb-2011 66VIY99 3007928905 Norwich Pharmaceuticals United States
 
SG5-0426175-4/4/1 14-Feb-2011 66VIY99 1000432766 Hex Ag Germany
 
SG5-0426175-4/5/1 14-Feb-2011 66VIY99 1000432766 Hex Ag Germany
 
SG5-0426175-4/6/1 14-Feb-2011 66VIY99 3006707930 Polfa Ul Poland
 
SG5-0426175-4/7/1 14-Feb-2011 66VIY99 3007928905 Norwich Pharmaceuticals United States
 
SG5-0426173-9/1/1 14-Feb-2011 66VIY99 3007928905 Norwich Pharmaceuticals United States
 
SG5-0426173-9/3/1 14-Feb-2011 66VIY99 3006707930 Polfa Ul Poland
 
SG5-0426174-7/2/1 14-Feb-2011 66VIY99 3007928905 Norwich Pharmaceuticals United States
 
SG5-0426038-4/1/1 16-Feb-2011 66VIY99 3000123645 Eli Lilly And Company United States
 
SG5-0426617-5/1/1 16-Feb-2011 66VIY99 3000123645 Eli Lilly And Company United States
 
SG5-0426617-5/1/2 16-Feb-2011 66VIY99 3000123645 Eli Lilly And Company United States
 
SG5-0426701-7/1/1 16-Feb-2011 66VIY99 3000123645 Eli Lilly And Company United States
 
W69-3179669-3/3/1 17-Feb-2011 66VQR99 3006336920 Fuda Oceanic Biochemical Industry Co Ltd China
 
KM6-0049332-4/2/1 03-Feb-2011 66YAY99 3004698324 Zhaoqing Winly Foreign Trade Develo China
 
KM6-0049332-4/3/5 03-Feb-2011 66YBY99 3004698324 Zhaoqing Winly Foreign Trade Develo China
 
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