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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 61-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-6998191-9/1/3 05-Jan-2011 61BCB04 3003369663 Cadila Healthcare Ltd India
 
AEK-8358985-9/5/1 07-Jan-2011 61ECA09 3008562907 Fahul Karim Bangladesh
 
H77-0124176-9/15/1/B 05-Jan-2011 61FBL21 3003452796 Reckitt Benckiser India
 
H77-0124176-9/15/1/C 05-Jan-2011 61FBL21 3003452796 Reckitt Benckiser India
 
H77-0124176-9/15/1/D 05-Jan-2011 61FBL21 3003452796 Reckitt Benckiser India
 
112-6727277-4/1/1 06-Jan-2011 61FDA55 3005564158 Cipla Ltd India
 
112-6601951-5/2/1 05-Jan-2011 61GCL80 3007056005 Pharmeks Dis Ticaret Ltd Sti Turkey
 
112-6601951-5/2/2 05-Jan-2011 61GCL80 3007056005 Pharmeks Dis Ticaret Ltd Sti Turkey
 
112-5112910-6/1/1 07-Jan-2011 61HBJ99 3008020727 Mesk Al Zahrah Tradking United Arab Emirates
 
224-2071086-9/1/2 11-Jan-2011 61HBY99 3007103959 Camellia Corporation Korea, Republic Of (South)
 
M21-0743021-9/1/1 31-Jan-2011 61HCA03 3006623417 Granules India Limited India
 
112-7013808-7/1/1 05-Jan-2011 61HCK43 3007487510 Park Kyung Hoon Korea, Republic Of (South)
 
112-5190061-3/1/1 06-Jan-2011 61HCO99 3008035461 Red Horse Products United Kingdom
 
112-5190061-3/1/2 06-Jan-2011 61HCO99 3008035461 Red Horse Products United Kingdom
 
880-0081334-0/3/1 10-Jan-2011 61JAY99 3001321966 Fujian Provincial Medicines & Health Products Imp & Exp Corp China
 
AEK-8362267-6/1/2 06-Jan-2011 61JCA08 3008620189 Anindya Ghosh India
 
112-7946998-8/1/1 04-Jan-2011 61JCA16 3005727321 Astrazeneca K.K. Japan
 
112-7663173-9/1/1 04-Jan-2011 61JCY14 1000165306 Merck Sharp & Dohme Research Laboratories Ltd United Kingdom
 
112-6587546-1/1/1 06-Jan-2011 61JDA08 3003023771 Roche Pharmaceuticals Canada
 
AEK-8358985-9/3/1 07-Jan-2011 61KCA54 3008562907 Fahul Karim Bangladesh
 
112-6502564-6/1/1 05-Jan-2011 61LDB38 1000645857 Bristol-Meyers Squibb Co United States
 
112-6666389-0/1/1 05-Jan-2011 61LIY13 1000543247 Toronto Research Chemicals Canada
 
UPS-0666206-4/1/1 06-Jan-2011 61MCA38 3008676098 Mr. Pratik Chadha India
 
112-6998191-9/1/1 05-Jan-2011 61MCB40 3003369663 Cadila Healthcare Ltd India
 
112-6998191-9/1/2 05-Jan-2011 61MCB40 3003369663 Cadila Healthcare Ltd India
 
112-7495864-7/1/1 04-Jan-2011 61MIB30 3003369663 Cadila Healthcare Ltd India
 
112-7808638-7/1/1 04-Jan-2011 61MLA99 3002906944 Apotex Inc. Canada
 
112-6485917-7/1/1 06-Jan-2011 61NDY78 2416101 Pfizer Inc. United States
 
AEK-8360973-1/1/1 06-Jan-2011 61PCA26 3008596260 N Sarojini United Arab Emirates
 
XXX-0272039-0/1/4 10-Jan-2011 61PCY11 3005992361 Sanofi-Aventis De Venezuela Venezuela
 
XXX-0272047-3/1/1 10-Jan-2011 61PCY11 3003502861 Productos Roche S.A. de C. V. Mexico
 
XXX-0272047-3/1/2 10-Jan-2011 61PCY18 3002809486 Eli Lilly Y Compania De Mexico S.A. de C.V. Mexico
 
UPS-0575691-7/1/1 06-Jan-2011 61PCY26 3008670237 Paola Doddiane Italy
 
XXX-0272047-3/1/3 10-Jan-2011 61PCY55 3006347951 Merck Sa De Cv Mexico
 
112-7663173-9/3/1 04-Jan-2011 61PCY60 3004437293 Novartis Switzerland
 
112-6475140-8/1/1 05-Jan-2011 61PDA51 3007373931 Centro Sambil Venezuela
 
112-6475140-8/1/2 05-Jan-2011 61PDA55 3007373931 Centro Sambil Venezuela
 
AEK-8358985-9/6/1 07-Jan-2011 61QCA99 3008562907 Fahul Karim Bangladesh
 
940-0174564-8/1/11 11-Jan-2011 61RCA11 3005139860 Pharm Invest Jv Ukraine
 
DO7-8237197-8/1/1 07-Jan-2011 61RCB99 3008653006 Marcel Gilliand Switzerland
 
940-0174564-8/1/13 11-Jan-2011 61RDA11 3005139860 Pharm Invest Jv Ukraine
 
AEK-8360964-0/4/2 06-Jan-2011 61SBA99 3008596148 Sd Sawheny India
 
112-5250590-8/1/1 06-Jan-2011 61SCA99 3008046244 Horsepower Bvba Belgium
 
UPS-0922681-8/1/1 25-Jan-2011 61TAA31 3008713860 Christos Siafakas Greece
 
112-7335546-4/1/1 04-Jan-2011 61TCA06 3006667835 Church & Dwight Canada Canada
 
UPS-0962581-1/1/5 21-Jan-2011 61TCY31 3006595385 Cadila Healthcare Limited India (Zyfine) India
 
AEK-8599019-6/1/1 11-Jan-2011 61TIY31 3002093078 Vasudha Pharma Chem Limited India
 
112-6632340-4/1/1 05-Jan-2011 61TSY29 1000437071 Slater & Frith Ltd. United Kingdom
 
004-5736752-2/4/1/A 10-Jan-2011 61VAL99 3007375794 Raymond Tagepaul Guyana
 
004-5736752-2/4/1/B 10-Jan-2011 61VAL99 3007375794 Raymond Tagepaul Guyana
 
KG2-0527351-2/1/16 10-Jan-2011 61VBA01 2210396 Novartis Pharmaceuticals Corp. United States
 
H77-0124176-9/3/1 05-Jan-2011 61VBL99 3005593764 Cheminnova Remedies Pvt. Ltd India
 
112-6892313-6/1/1 05-Jan-2011 61WAN45 3004085571 Pfizer France
 
020-0313878-7/15/1/B 03-Jan-2011 61WBL99 3003339852 Cosmec Spa Italy
 
020-0313878-7/15/1/C 03-Jan-2011 61WBL99 3003339852 Cosmec Spa Italy
 
AEK-8358985-9/4/1 07-Jan-2011 61XCA45 3008562907 Fahul Karim Bangladesh
 
112-5160241-7/1/1 07-Jan-2011 61XSY09 1000434913 Selectchemie AG Switzerland
 
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