• 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 64-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
EL0-0225636-9/38/1 09-Sep-2009 64AAK99 3007384562 Aci Limited Bangladesh
 
EL0-0225527-0/37/1 08-Sep-2009 64AAL99 3007384576 Zahid Enterprise Bangladesh
 
EL0-0225636-9/37/1 09-Sep-2009 64ABK99 3007384562 Aci Limited Bangladesh
 
BMU-0009127-8/2/1 30-Sep-2009 64ABR20 3003450804 Laboratorios Undra, S.A. De C.V. Mexico
 
BMU-0009127-8/2/2 30-Sep-2009 64ABR20 3003450804 Laboratorios Undra, S.A. De C.V. Mexico
 
DO7-8215703-9/1/4 30-Sep-2009 64BBA37 3003835430 University Of Pretoria South Africa
 
EG6-1768658-9/5/1 28-Sep-2009 64BDA40 3002808376 Apotex, Inc. Canada
 
112-7423823-0/1/1 03-Sep-2009 64BDB25 3003183014 Mrw Venezuela
 
112-7508746-1/1/1 03-Sep-2009 64GCA07 1000651745 Nova Nordisk Canada
 
112-8857265-7/1/1 09-Sep-2009 64GCA29 3003265951 Paladin Labs Inc Canada
 
396-0156740-5/8/1 30-Sep-2009 64GCB19 3007844890 Shalaks Pharmaceuticals Pvt Ltd India
 
XXX-0163320-6/1/1 17-Sep-2009 64GDA07 3002806821 MSD Organon BV Netherlands
 
H84-0099220-7/1/1/A 02-Sep-2009 64LCJ99 3008491351 Esapharma Srl Italy
 
H84-0099220-7/1/1/B 02-Sep-2009 64LCJ99 3002624255 Scanchemie Ltd. Germany
 
H84-0099220-7/1/1/C 02-Sep-2009 64LCJ99 3004144638 BELTAPHARM S.p.A. Italy
 
H84-0099220-7/1/1/D 02-Sep-2009 64LCJ99 3002624255 Scanchemie Ltd. Germany
 
H84-0099220-7/1/1/E 02-Sep-2009 64LCJ99 3004565771 Lachifarma Italy
 
H84-0099220-7/2/1/A 02-Sep-2009 64LCJ99 3008491351 Esapharma Srl Italy
 
H84-0099220-7/2/1/B 02-Sep-2009 64LCJ99 3002624255 Scanchemie Ltd. Germany
 
H84-0099220-7/2/1/C 02-Sep-2009 64LCJ99 3004144638 BELTAPHARM S.p.A. Italy
 
H84-0099220-7/2/1/D 02-Sep-2009 64LCJ99 3002624255 Scanchemie Ltd. Germany
 
605-4536760-3/1/1 24-Sep-2009 64LCS58 3001599766 Changzhou Jiaerke Pharmaceuticals Group Corp., Ltd. China
 
112-8858812-5/1/1 09-Sep-2009 64LCZ20 3003228982 Alcon Canada Inc Canada
 
551-8376755-2/48/1 16-Sep-2009 64MBL04 1000399435 Homeolab Inc. Canada
 
112-7296235-1/2/1 02-Sep-2009 64MCH01 3007520741 Sharp Pharmaceutical Ltd Ireland
 
112-7296235-1/3/1 02-Sep-2009 64MCH01 3007155961 Tianjin Tasly Group Co., Ltd. China
 
AEK-9670272-1/2/1 30-Sep-2009 64PCA02 3007720412 Sunil A Dave India
 
DO7-8214588-5/1/1 22-Sep-2009 64RDK99 3007662075 Puz Piedad Ochoa Colombia
 
AEK-9671164-9/1/1 30-Sep-2009 64UCA06 3007748231 Drs Trythall Hoy Dabies Pte Ltd Singapore
 
396-0156740-5/7/1 30-Sep-2009 64XAJ12 3007844890 Shalaks Pharmaceuticals Pvt Ltd India
 
-
-