• 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 62-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
DO7-8217867-0/1/2 28-Oct-2009 62AAB04 3007866746 Fazal Bashir Jamal India
 
DO7-8217867-0/2/1 28-Oct-2009 62CCB99 3007866746 Fazal Bashir Jamal India
 
DO7-8217867-0/2/4 28-Oct-2009 62CCB99 3007866746 Fazal Bashir Jamal India
 
H77-0117993-6/1/1 23-Oct-2009 62FBL18 3007851531 Huatai Chemical Xianing Co. Ltd China
 
AEK-9959540-3/1/1 20-Oct-2009 62FCY53 3001682959 Maximo Gomez P C Por A Dominican Republic
 
AEK-9959540-3/1/2 20-Oct-2009 62FCY53 3001682959 Maximo Gomez P C Por A Dominican Republic
 
112-3406007-0/1/1 19-Oct-2009 62GAB49 3007558283 Bayer Materialscience Llc United States
 
112-7963911-9/1/1 17-Oct-2009 62GBL99 3007631588 Weleda Ag Germany
 
551-8395440-8/3/1 01-Oct-2009 62GBY99 1000399435 Homeolab Inc. Canada
 
112-8045898-8/1/1 06-Oct-2009 62GCE42 3007644770 Igor Shikhman Spain
 
112-7856514-1/2/1 19-Oct-2009 62GCJ99 3007614538 Sda Industries Ltd India
 
112-8083943-5/1/1 06-Oct-2009 62GDE49 3007650553 Church & Dwight Srl De Cv Mexico
 
334-2761279-2/1/1 05-Oct-2009 62GIB49 3002906944 Apotex Inc. Canada
 
AEK-9959540-3/1/3 20-Oct-2009 62HCY03 3001682959 Maximo Gomez P C Por A Dominican Republic
 
AEK-9673591-1/1/1 23-Oct-2009 62HDA99 3006992513 Fab Medical Ltd United Kingdom
 
300-9076185-7/1/1 15-Oct-2009 62HDY99 3007748192 Coconut Growers Association Trinidad & Tobago
 
300-9076185-7/2/1 15-Oct-2009 62HDY99 3006169472 Dominicana Coconut Products Dominica
 
AEK-6600806-7/2/1 15-Oct-2009 62KCA10 3007840450 Sudarshan Sharma India
 
112-1761719-3/1/1 30-Oct-2009 62LDJ40 3003647459 Unique Pharmaceutical Laboratories India
 
KR3-0072413-4/1/2 08-Oct-2009 62MAY08 3004671069 GRUPO WARNER LAMBERT MEXICO S DE RL DE CV Mexico
 
KR3-0072413-4/1/3 08-Oct-2009 62MAY08 3004671069 GRUPO WARNER LAMBERT MEXICO S DE RL DE CV Mexico
 
KR3-0072413-4/1/4 08-Oct-2009 62MAY08 3004671069 GRUPO WARNER LAMBERT MEXICO S DE RL DE CV Mexico
 
KR3-0072413-4/1/5 08-Oct-2009 62MAY08 3004671069 GRUPO WARNER LAMBERT MEXICO S DE RL DE CV Mexico
 
AEK-6600806-7/1/1 15-Oct-2009 62OCA43 3007840450 Sudarshan Sharma India
 
112-8281000-4/2/1 17-Oct-2009 62OCB03 3004055168 Les Laboratories Servier Industrie France
 
112-8281000-4/4/1 17-Oct-2009 62OCB03 1000289508 Braco Spa Italy
 
112-8018757-9/1/1 17-Oct-2009 62OCK26 3003374081 Merk Sharp & Dohme Belgium
 
112-7787156-5/1/1 19-Oct-2009 62OCN14 3005845467 Novartis Inst For Biomed Researc United States
 
336-8586607-4/1/1 15-Oct-2009 62OCS48 3002808007 Roche Ireland Limited Ireland
 
AEK-6600647-5/1/1 13-Oct-2009 62ODA12 3007839723 Mohamed Ibrahim Egypt
 
112-9379732-3/1/1 22-Oct-2009 62ODA19 3003702645 Astrazeneca Pty Ltd Australia
 
112-6308473-6/1/1 30-Oct-2009 62TCY04 3003662015 Novartis Farma Spa Italy
 
AM4-0195399-8/4/4 08-Oct-2009 62UAY99 3003183817 Canel'S Sa De Cv Mexico
 
551-8397630-2/8/1 01-Oct-2009 62UBL99 1000399435 Homeolab Inc. Canada
 
112-1839443-8/2/1 30-Oct-2009 62UCC08 3005509930 Janssen Silag Farmaceutica Ltd Brazil
 
112-8267919-3/1/1 17-Oct-2009 62UDE08 1000328785 McNeil Consumer Healthcare Canada
 
112-7013794-9/3/1 17-Oct-2009 62VCA18 3007487342 Marco A Alvarez Venezuela
 
112-7013794-9/1/1 17-Oct-2009 62VCA99 3004894729 GlaxoSmithKline, S.A. Spain
 
655-1494452-3/1/5 29-Oct-2009 62VCS42 3002691261 Assia Chemical Ind Ltd Israel
 
655-1494452-3/1/4 29-Oct-2009 62VCS42 3002691261 Assia Chemical Ind Ltd Israel
 
655-1494452-3/1/3 29-Oct-2009 62VCS42 3002691261 Assia Chemical Ind Ltd Israel
 
655-1494452-3/1/2 29-Oct-2009 62VCS42 3002691261 Assia Chemical Ind Ltd Israel
 
655-1494452-3/1/1 29-Oct-2009 62VCS42 3002691261 Assia Chemical Ind Ltd Israel
 
112-7511238-4/1/1 17-Oct-2009 62VCY45 3000508362 Roche Pharmaceuticals United States
 
AR6-9240552-5/1/1/A 13-Oct-2009 62WAL99 3002978414 Dr. Nona International Ltd Israel
 
AR6-9240552-5/1/1/B 13-Oct-2009 62WAL99 3002978414 Dr. Nona International Ltd Israel
 
AR6-9240552-5/1/1/C 13-Oct-2009 62WAL99 3002978414 Dr. Nona International Ltd Israel
 
DM0-0920668-9/35/1 13-Oct-2009 62WBL17 1000300384 Colgate Palmolive SA de CV Mexico
 
DM0-0920668-9/36/1 13-Oct-2009 62WBL17 1000300384 Colgate Palmolive SA de CV Mexico
 
-
-