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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
112-6831239-7/1/1 28-Apr-2009 60CDR21 3006595385 Cadila Healthcare Limited India (Zyfine) India
 
XXX-0217778-1/1/5 21-Apr-2009 60LAB05 3005203073 Bayer S.A. Guatemala
 
XXX-0217778-1/1/6 21-Apr-2009 60LAB05 3005203073 Bayer S.A. Guatemala
 
DZ1-0386180-0/48/1 14-Apr-2009 60LBA05 3007326071 Gansu Light Inustrial Products Import And Export Corp. Ltd China
 
DZ1-0386180-0/56/1 14-Apr-2009 60LBA05 3007326071 Gansu Light Inustrial Products Import And Export Corp. Ltd China
 
411-8166595-5/12/2 16-Apr-2009 60LBJ99 3004561261 Sha Maganlal Chunilal Gandhi India
 
411-8166595-5/12/1 16-Apr-2009 60LBL07 3004561261 Sha Maganlal Chunilal Gandhi India
 
DZ1-0386180-0/80/1 14-Apr-2009 60LBY04 3007326071 Gansu Light Inustrial Products Import And Export Corp. Ltd China
 
988-0129161-2/1/1 15-Apr-2009 60LBY99 3007456557 Brands Rmj P L Australia
 
988-0129161-2/1/2 15-Apr-2009 60LBY99 3007456557 Brands Rmj P L Australia
 
AEK-9596245-8/3/1/B 08-Apr-2009 60LBZ01 3004477110 Prodemdis Canada
 
UPS-4185263-1/1/4 02-Apr-2009 60LCA01 3007426631 Miguel Fernandez Carrion Mexico
 
DO7-8211249-7/1/8 23-Apr-2009 60LCA01 3007480327 Maccalid Misquith India
 
DO7-8211249-7/1/1 23-Apr-2009 60LCA05 3007480327 Maccalid Misquith India
 
AEK-9847783-5/1/1 20-Apr-2009 60LCK99 3007478530 Hashim Mihdi Kazazz Syrian Arab Republic
 
UPS-0043158-2/8/1 28-Apr-2009 60LDJ99 3006780965 Global Ind. Nigeria Ltd Nigeria
 
T94-0050131-6/1/1 28-Apr-2009 60LDK01 3004944972 Laboratorio Magnachem International, S.A. Dominican Republic
 
T94-0050131-6/1/2 28-Apr-2009 60LDK01 3004944972 Laboratorio Magnachem International, S.A. Dominican Republic
 
112-7030855-7/1/2 24-Apr-2009 60LIY83 3007489076 Esaam El Din Abdelaal Mostafa Egypt
 
112-6816824-5/1/1 13-Apr-2009 60NDC14 3007450082 Dr.Layla Al Onaizi Saudi Arabia
 
112-7018095-6/2/1 08-Apr-2009 60QCK82 3007250542 Cenexi France
 
XXX-0238116-9/1/1 15-Apr-2009 60QDK40 3006142212 Ropsohn Therapeutics Ltda Colombia
 
UPS-4413226-2/1/24 28-Apr-2009 60QDK40 3005579246 Hospira Inc. United States
 
K51-0066343-1/3/1 03-Apr-2009 60QDK46 3007237085 JAMES BROWN PHARMA Ecuador
 
K51-0066343-1/3/2 03-Apr-2009 60QDK46 3007237085 JAMES BROWN PHARMA Ecuador
 
XXX-0238116-9/1/2 15-Apr-2009 60QDK67 3006142212 Ropsohn Therapeutics Ltda Colombia
 
UPS-4413226-2/1/35 28-Apr-2009 60QDY46 3000203232 Apothecure, Inc United States
 
112-6907222-2/1/1 15-Apr-2009 60RAE18 3004990154 Roche Australia
 
BIM-1108097-0/15/1/B 02-Apr-2009 60SAY13 3003467881 Coyoacan Quimica, S.A. De C.V. Mexico
 
761-0072002-8/6/1 06-Apr-2009 60XCA17 3007339169 Pymepharco Vietnam
 
761-0072002-8/7/1 06-Apr-2009 60XCA17 3007339169 Pymepharco Vietnam
 
112-7001438-7/1/2 24-Apr-2009 60XCB17 3005968673 Sanofi Aventis De Mexico Sa De Mexico
 
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