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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
XXX-0217722-9/1/1 26-Mar-2009 61FCB54 3002806462 Bayer Pharma AG Germany
 
M21-0739461-3/1/1 02-Mar-2009 61GAA57 3006497359 Research Pharmaceutical Colombia
 
UPS-3811806-1/1/1 02-Mar-2009 61HAY99 3006043562 Laboratoire Prodene Klintescape Leader France
 
D11-0117364-3/4/1 05-Mar-2009 61HBJ05 3004168876 Procter & Gamble Mfg (Thailand) Ltd Thailand
 
AEK-9161320-4/1/2 26-Mar-2009 61JCA09 3007392669 Saudi Aramco Medical Services Saudi Arabia
 
AEK-9150025-2/2/1 10-Mar-2009 61JCA14 3007247366 Andrea Addison United Kingdom
 
112-6722879-2/1/1 11-Mar-2009 61JCA16 3002807978 Ranbaxy Laboratories Ltd.- Sirmour India
 
XXX-0217707-0/1/1 26-Mar-2009 61JCB15 3007346983 Schering-Plough United Kingdom
 
DO7-8210250-6/1/2 19-Mar-2009 61KDB05 3006476818 Narayanapph Pharmaceutical Chemist India
 
AEK-9161316-2/1/1 26-Mar-2009 61LCA38 3007392580 Shepherd India Eximp India
 
M76-9655450-1/25/1 12-Mar-2009 61LCL14 3007337697 Xtrium United States
 
AEK-9161479-8/1/1 26-Mar-2009 61MCA38 3007401730 Tali Sahar Israel
 
AEK-9161479-8/1/2 26-Mar-2009 61MCA38 3007401730 Tali Sahar Israel
 
AEK-9161479-8/1/3 26-Mar-2009 61MCA38 3007401730 Tali Sahar Israel
 
XXX-0211988-2/1/1 20-Mar-2009 61MCB35 3004141029 Abbott Laboratories Argentina Sa Argentina
 
UPS-3784105-1/1/1 10-Mar-2009 61NCB05 3007333340 Itep Ag Switzerland
 
XXX-0217707-0/1/4 26-Mar-2009 61NCB78 3004182033 Pfizer Sa De Cv Mexico
 
XXX-0217707-0/1/2 26-Mar-2009 61PCB55 3007049507 Merck Austria
 
AEK-9161315-4/2/2 26-Mar-2009 61TCA99 3007392544 Marlies Schulze Halberg Germany
 
554-9625679-7/1/1 11-Mar-2009 61TCS29 3004987008 Alkaloids Private Limited India
 
112-6703294-7/1/1 04-Mar-2009 61TCY99 3005072567 Apotex Inc. Canada
 
DO7-8208825-9/2/1 11-Mar-2009 61TDY99 3007308348 Reit Rajak India
 
AEK-9157077-6/1/3 11-Mar-2009 61VDA99 3007323497 Mr Madrnath India
 
AEK-9157527-0/1/1 13-Mar-2009 61WAA99 3007329049 S.D. Irani India
 
H67-1329062-4/2/1 17-Mar-2009 61WBJ04 3004083746 Lab Por Peru
 
AEK-9161116-6/1/2 19-Mar-2009 61WCJ18 3007388700 Seth Medicos India
 
AEK-9161116-6/2/1 19-Mar-2009 61WDA45 3007388700 Seth Medicos India
 
AEK-9158510-5/4/1 10-Mar-2009 61XCA45 3007343286 Sesha Reddy India
 
AEK-9157077-6/2/1 11-Mar-2009 61XCA45 3007323497 Mr Madrnath India
 
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