• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Import Refusal Report

  • Print
  • Share
  • E-mail
-

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
BHC-5003124-2/13/1 21-Aug-2009 61ADA06 3007576384 Global Pharmaceutical United States
 
442-6235813-6/1/1 26-Aug-2009 61EAS99 3007686024 Nycomed Gmbh Germany
 
112-5930444-5/1/1 19-Aug-2009 61ECR11 3003448273 Neuland Laboratories Limited India
 
KH5-0042099-8/1/1 04-Aug-2009 61ECS08 3003227156 Mylan Laboratories Ltd. (Unit 7) India
 
112-6384528-4/1/1 19-Aug-2009 61FDA54 3006383915 1 A Pharma Gmbh Germany
 
112-6699344-6/1/1 21-Aug-2009 61FIY54 3005061824 Alkan Pharma Co Egypt
 
112-7279577-7/2/1 26-Aug-2009 61GAP70 3005442082 Zambon Italia Srl Italy
 
112-6628288-1/1/1 19-Aug-2009 61GCS81 3004070741 Applichem Gmbh Germany
 
429-0845391-5/14/4 28-Aug-2009 61HAJ99 3007728651 Ban Labs Ltd India
 
EBH-0064571-6/70/1/A 20-Aug-2009 61HBJ05 3003725684 Unilever Philippines, Inc. Philippines
 
AEK-9896943-5/1/1 03-Aug-2009 61HCY99 3007650209 Emc Brucargo Belgium
 
BHC-5003124-2/23/1 21-Aug-2009 61HDH32 3007702691 Ranbaxy-Generic Products United States
 
112-6910866-1/1/2 19-Aug-2009 61JIY08 3004433886 Pfizer Bv Netherlands
 
112-6910866-1/2/2 19-Aug-2009 61JIY09 3002270233 Sigma-Aldrich Chamie Gmbh Germany
 
BHC-5003124-2/27/1 21-Aug-2009 61KDA06 3001611969 Excellium Pharmaceutical, Inc United States
 
BHC-5003124-2/4/3 21-Aug-2009 61KDB34 3006234685 Mylan Lab Inc United States
 
112-7279577-7/1/2 26-Aug-2009 61LAJ08 3002844995 Drossapharm Ag Switzerland
 
112-6878540-2/1/1 20-Aug-2009 61LAK40 3003228982 Alcon Canada Inc Canada
 
AEK-9900895-1/1/1 03-Aug-2009 61LCY29 3004786430 Sanofi Aventis France
 
BHC-5003124-2/31/1 21-Aug-2009 61LDK27 3006614085 Eisai Inc United States
 
AEK-9915033-2/1/1 31-Aug-2009 61LIY34 1000370240 Penn Pharmaceuticals Services Ltd. United Kingdom
 
186-5373203-4/1/1 31-Aug-2009 61LKQ14 3006003481 Empack Canada
 
XXX-0256051-5/1/2 03-Aug-2009 61MCB41 3005323307 Abbott Laboratories Argentina S.A. Argentina
 
BHC-5003124-2/6/2 21-Aug-2009 61MDA35 3007702682 Abbott Pharmaceuticals United States
 
112-6605776-2/1/1 03-Aug-2009 61MIY99 3006574596 Durbin United Kingdom
 
AEK-9896420-4/1/1 03-Aug-2009 61NCA80 3007647462 Dr Albert Woods Belgium
 
XXX-0256051-5/1/1 03-Aug-2009 61NCB05 1035048 GlaxoSmithKline United States
 
112-6387575-2/1/1 19-Aug-2009 61NCF29 3002906944 Apotex Inc. Canada
 
112-6699344-6/1/2 21-Aug-2009 61NCY55 3005642107 Sanor Egypt
 
112-6699344-6/1/3 21-Aug-2009 61NCY77 3006524263 Glaxosmith Kline Egypt
 
BHC-5003124-2/25/1 21-Aug-2009 61NDA82 3007702687 Janssen Pharmaceuticals United States
 
112-7296501-6/1/1 26-Aug-2009 61NIB05 3006891219 Bayer Pharmaceutircals Corp United States
 
112-7296501-6/1/2 26-Aug-2009 61NIB05 3007520787 Pfizer Pharmaceuticals Inc United States
 
112-8029957-2/2/1 19-Aug-2009 61PCB56 3007642688 Cosmos Life Sciences India
 
112-7031119-7/1/1 25-Aug-2009 61PCB62 3007489087 Jaskiran Bhatia India
 
112-8029957-2/1/1 19-Aug-2009 61PCP99 3002807664 Merck Sharp & Dohme (Italia) S.p.A. Italy
 
BHC-5003124-2/12/1 21-Aug-2009 61PDA61 1000522100 GlaxoSmithKline LLC United States
 
112-6368217-4/1/1 19-Aug-2009 61PIK17 3002807186 Valeant Pharmaceuticals International Canada
 
112-6640967-4/1/1 03-Aug-2009 61PIS26 3007402332 Wockhardt United Kingdom
 
112-6910866-1/2/1 19-Aug-2009 61PIY26 3002270233 Sigma-Aldrich Chamie Gmbh Germany
 
112-6910866-1/1/1 19-Aug-2009 61PIY61 3005385999 Glaxosmithkline Bv Netherlands
 
BHC-5003124-2/15/1 21-Aug-2009 61QDQ03 1313525 Bausch & Lomb Inc United States
 
112-6135245-7/4/8 25-Aug-2009 61RCE99 3002512569 Metabolics Ltd United Kingdom
 
112-4739630-5/2/1 19-Aug-2009 61TCB12 3007158582 Beacon Pharmaceuticals Ltd. Bangladesh
 
112-7280064-3/1/1 26-Aug-2009 61TDL17 3003712444 Glaxosmithkline Exp United Kingdom
 
KM6-0111585-0/7/1 17-Aug-2009 61WBL28 3007620079 FEDGLOBE (PVT) LIMTED Pakistan
 
KM6-0111585-0/7/2 17-Aug-2009 61WBL28 3007620079 FEDGLOBE (PVT) LIMTED Pakistan
 
BHC-5003124-2/23/3 21-Aug-2009 61WDL23 3007702691 Ranbaxy-Generic Products United States
 
112-7014113-1/1/1 19-Aug-2009 61XIY99 3007487325 Claudine Rill Canada
 
-
-