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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 60-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-3559308-7/1/1 21-Jul-2008 60CAK53 3004437354 Novartis Israel
 
112-3465107-6/1/1 21-Jul-2008 60LAA05 3004715789 Bayer Portugal Sa Portugal
 
M21-0737915-0/3/1 02-Jul-2008 60LAL21 3004850451 Wendt-Chemie Vertriebsges Mbh & Co. Germany
 
AEK-9118589-8/1/1 08-Jul-2008 60LAY01 3006222236 Johnson & Johnson Pacific Australia
 
U47-0460734-8/44/1 23-Jul-2008 60LAY63 3004616133 Cosmos Confectionary Co.,Ltd. Korea, Republic Of (South)
 
AEG-2009913-2/5/1 31-Jul-2008 60LBA99 1000638248 Mead Johnson De Mexico Sa De Cv Mexico
 
XXX-0210608-7/1/2 03-Jul-2008 60LBE01 3003724366 GlaxoSmithKline Panama S.A. Panama
 
315-7882213-7/4/1 10-Jul-2008 60LBJ99 3000310824 Mata Amritanandamayi Mission Trust India
 
AEK-9677686-5/1/1 14-Jul-2008 60LBJ99 3006731793 Satoru Yoshino Japan
 
AYG-1001538-1/15/1 19-Jul-2008 60LBJ99 3004328659 AABHAR INTERNATIONAL India
 
AYG-1001538-1/16/1 19-Jul-2008 60LBJ99 3004328659 AABHAR INTERNATIONAL India
 
FS2-8010297-1/4/1 10-Jul-2008 60LBO04 3004313288 Xiamen Traditional Chinese Medicine Co., Ltd. China
 
FS2-8010297-1/4/2 10-Jul-2008 60LBO04 3004313288 Xiamen Traditional Chinese Medicine Co., Ltd. China
 
FS2-8010297-1/4/3 10-Jul-2008 60LBO04 3004313288 Xiamen Traditional Chinese Medicine Co., Ltd. China
 
XXX-0210608-7/1/9 03-Jul-2008 60LBR01 3005275296 Glaxosmithkline Costa Rica S A Costa Rica
 
XXX-0210608-7/1/11 03-Jul-2008 60LBR01 3004807344 LABORATORIOS ALFA C. A. Dominican Republic
 
AEK-9506847-0/1/1 21-Jul-2008 60LCA69 3006986322 Bin Seena Health Limited United Kingdom
 
XXX-0154562-4/1/1/H 07-Jul-2008 60LDJ99 3006780965 Global Ind. Nigeria Ltd Nigeria
 
112-3142105-1/1/1 21-Jul-2008 60RDA19 3004464597 Newport Pharmaceutical Costa Rica
 
300-1971547-1/6/1 08-Jul-2008 60SBL09 3004254426 Thakar Exports India
 
300-1971547-1/5/1 08-Jul-2008 60SBL09 3004254426 Thakar Exports India
 
AYG-1001538-1/17/1 19-Jul-2008 60SBR99 3004328659 AABHAR INTERNATIONAL India
 
M21-0737915-0/6/1 02-Jul-2008 60SCA23 3004850451 Wendt-Chemie Vertriebsges Mbh & Co. Germany
 
M21-0737782-4/1/1 14-Jul-2008 60WCA01 3006094247 Research Pharmaceutical Co Ltd China
 
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