• 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
946-0616444-3/64/1 02-Oct-2009 61FBL21 3003740869 Reckitt Benkiser Ltd United Kingdom
 
946-0616444-3/65/1 02-Oct-2009 61FBL21 3003740869 Reckitt Benkiser Ltd United Kingdom
 
112-7186268-5/1/1 02-Oct-2009 61GDA57 3002807936 Productos Roche Quimicos E Farmaceuticos Brazil
 
112-9232533-2/1/1 09-Oct-2009 61GDB85 3001229217 Zuellig Pharma Corporation Philippines
 
BGK-0050845-8/10/1 15-Oct-2009 61HAL05 3006408300 Medicia Corp United States
 
016-1128428-0/5/2 05-Oct-2009 61HBJ99 3005234831 Paras Pharmaceutical Ltd India
 
112-3919130-0/1/1 19-Oct-2009 61HBJ99 3006189490 Innovation Africa United Kingdom
 
016-1128428-0/2/1 05-Oct-2009 61HBL99 3003452796 Reckitt Benckiser India
 
336-6928574-7/2/1 30-Oct-2009 61HBL99 3003703619 Schulke & Mayr Gmbh Germany
 
016-1128428-0/1/1 05-Oct-2009 61HBY99 1000353365 Reckitt & Colman (Overseas) Ltd. United Kingdom
 
BGK-0925340-3/30/1/A 13-Oct-2009 61HBY99 3004294606 ITN Pakistan Export Enterprises Pakistan
 
BGK-0925340-3/30/1/B 13-Oct-2009 61HBY99 3004294606 ITN Pakistan Export Enterprises Pakistan
 
112-7720822-2/2/1 06-Oct-2009 61HCK43 3002808072 Santen Pharm. Co., Ltd. Japan
 
AEK-6600806-7/1/2 15-Oct-2009 61JCA08 3007840450 Sudarshan Sharma India
 
112-8281000-4/3/1 17-Oct-2009 61JCB16 3004463081 Astrazeneca Argentina Sa Argentina
 
112-7297034-7/1/2 19-Oct-2009 61JNS08 3006657822 Daiichi Sankyo Co Japan
 
112-7297034-7/1/1 19-Oct-2009 61JNS13 3006657822 Daiichi Sankyo Co Japan
 
112-9154522-9/1/1 22-Oct-2009 61KCR04 3003981475 Biocon Limited India
 
AEK-9935586-5/1/9 13-Oct-2009 61LCA38 3007803880 Deepali India
 
AEK-6600806-7/3/1 15-Oct-2009 61LCA38 3007840450 Sudarshan Sharma India
 
AEK-9938505-2/1/1 19-Oct-2009 61LCA38 3007826593 Horizon International Cargo Ltd United Kingdom
 
DO7-8217867-0/2/2 28-Oct-2009 61LCB38 3007866746 Fazal Bashir Jamal India
 
DO7-8217867-0/2/3 28-Oct-2009 61LDB99 3007866746 Fazal Bashir Jamal India
 
112-8066778-6/1/1 06-Oct-2009 61MCA38 3005179453 Torrent Do Brasil Ltda Brazil
 
AEK-9946978-1/1/1 19-Oct-2009 61MCA38 3007536453 Sk Kannan India
 
AEK-9946978-1/1/2 19-Oct-2009 61MCA38 3007536453 Sk Kannan India
 
112-8066778-6/1/3 06-Oct-2009 61NCA66 3003411289 Novaquima Sigma Pharma Brazil
 
112-7402081-0/1/1 19-Oct-2009 61NCA69 3004148917 Pfizer Ssrl Argentina
 
112-7964545-4/1/1 17-Oct-2009 61NCB29 3007631654 Plit Krakow Sp Z Poland
 
112-9165915-2/1/1 08-Oct-2009 61NCB76 3002906944 Apotex Inc. Canada
 
AEK-9935586-5/1/4 13-Oct-2009 61PCA26 3007803880 Deepali India
 
AEK-9935586-5/1/3 13-Oct-2009 61PCA31 3007803880 Deepali India
 
112-2713240-7/1/2 19-Oct-2009 61PCA56 3005029956 Torrent Pharmaceuticals Ltd. India
 
112-8033325-6/1/1 17-Oct-2009 61PCB55 3001662788 Merck Pharmaceuticals United Kingdom
 
DO7-8217867-0/1/1 28-Oct-2009 61PCB99 3007866746 Fazal Bashir Jamal India
 
112-6308473-6/2/1 30-Oct-2009 61PCY17 3002806895 Eli Lilly Italia S.P.A. Italy
 
112-8268006-8/1/1 17-Oct-2009 61PDA55 3002808204 Sino-American Shanghai Squibb Ltd. China
 
112-2713240-7/1/1 19-Oct-2009 61PDB55 3004515884 Micro Labs Limited - Unit III India
 
AEK-6601874-4/1/1 23-Oct-2009 61SBO99 3007302669 Cure Herbals Pakistan
 
WTV-0018839-4/1/1 28-Oct-2009 61TBC06 3006334963 Rfd Beaufort Limited Iran
 
112-2639008-9/1/1 28-Oct-2009 61TCA99 3005027448 Janssen-Cilag Sa Belgium
 
KM6-0043197-7/14/1 30-Oct-2009 61VBL99 3005179578 Promed Laboratories (P) Ltd. India
 
M21-0740475-0/3/1 16-Oct-2009 61WCA99 3006094247 Research Pharmaceutical Co Ltd China
 
AEK-9935586-5/1/2 13-Oct-2009 61XCA45 3007803880 Deepali India
 
112-6257928-0/2/1 30-Oct-2009 61XCP99 3004195227 Glaxo Wellcome S.A. Spain
 
-
-