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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
112-6991667-6/1/1 11-Jan-2012 61EAK08 3008312569 Dr. Jamie Mejia Mexico
 
AEK-8389663-5/1/1 06-Jan-2012 61ECA09 3009232381 C Sam No India
 
DO7-8258162-6/1/1 06-Jan-2012 61ECB06 3009231269 Emran Shamo Jordan
 
112-6220396-5/1/1 07-Jan-2012 61ECB09 3002807565 Merck Frosst Canada, Ltd. Canada
 
112-6891599-2/1/3 12-Jan-2012 61ECC09 3001880897 Merck Sharp Brazil
 
112-9564542-2/2/1 06-Jan-2012 61FCH56 3004378927 Emcure Pharmaceuticals Ltd. India
 
XXX-0176546-1/2/25 24-Jan-2012 61FDB14 3003332931 Laboratorios Bonin Guatemala
 
XXX-0176546-1/2/7 24-Jan-2012 61FDB30 3004119887 Panzyma Laboratories Nicaragua
 
112-5229824-0/1/1 04-Jan-2012 61H43 3002617140 Janssen Pharmaceutica Mexico
 
ES6-4008285-6/5/1/A 25-Jan-2012 61HBU99 1000413107 Gulf Center For Soap And Chemical Industries United Arab Emirates
 
ES6-4008285-6/5/1/D 25-Jan-2012 61HBU99 1000413107 Gulf Center For Soap And Chemical Industries United Arab Emirates
 
KL1-0165679-3/5/1 10-Jan-2012 61HBY99 3008491351 Esapharma Srl Italy
 
112-5358878-9/1/1 20-Jan-2012 61HCK99 3007061608 Phage Therapy Center Georgia
 
XXX-0176546-1/2/33 24-Jan-2012 61HDB43 3003916517 Unipharma International, SA Guatemala
 
XXX-0176507-3/1/8 04-Jan-2012 61JCA08 3008153955 Solrex Pharmaceuticals Co India
 
112-0177587-6/1/2 06-Jan-2012 61JCA08 3007202378 Piramal Healthcare India
 
112-6236345-4/1/1 07-Jan-2012 61LCA38 3002888623 Sanofi Pasteur Limited - Cannaught Campus Canada
 
112-7398660-8/1/1 13-Jan-2012 61MCB38 1000197265 Glaxo Operations Uk Limited United Kingdom
 
112-6053116-0/1/1 31-Jan-2012 61MCB38 3009078509 Glaxosmithkline Australia
 
112-5399936-6/1/1 20-Jan-2012 61MCF99 3003346516 Biocodes France
 
916-2236379-3/1/1 19-Jan-2012 61MCS13 3002808158 Siegfried Ltd Switzerland
 
916-2236379-3/2/1 19-Jan-2012 61MCS13 3002808158 Siegfried Ltd Switzerland
 
112-9497894-9/1/2 06-Jan-2012 61MIH41 3002989060 Procaps S.A. Colombia
 
BKL-0210386-0/1/1 30-Jan-2012 61MQS44 3005554260 RA Chem Pharma Limited India
 
AEK-8390027-0/4/1 06-Jan-2012 61NCA05 3009241718 Mr Madan Paul India
 
XXX-0176507-3/1/5 04-Jan-2012 61NCA78 3004124371 Pfizer ltd India
 
112-8928407-1/1/1 07-Jan-2012 61NCF37 3004574916 Active Di Cavallari Roberta Italy
 
112-8519235-1/1/1 12-Jan-2012 61NCS24 3002913672 Assia Chemical Industries - Teva Tech Site Israel
 
112-7971949-0/1/1 07-Jan-2012 61NCY76 3002807060 Mylan Pharmaceuticals ULC Canada
 
112-6053116-0/2/2 31-Jan-2012 61NCY83 3003620101 Alpha Pty Australia
 
AEK-8620348-2/1/1 25-Jan-2012 61PAA55 3003596612 Sanofi-Aventis U.S. LLC United States
 
112-9941426-2/1/1 06-Jan-2012 61PCA02 3002393210 Takeda Pharmaceuticals North America, Inc. United States
 
112-0177587-6/1/1 06-Jan-2012 61PCA62 3005831271 Sun Pharmaceutical Industries India
 
XXX-0176504-0/1/1 04-Jan-2012 61PCC55 3006452206 Abbott Group Bricocia Pharma India
 
XXX-0176546-1/2/26 24-Jan-2012 61PDB55 3005202412 Intermed India
 
XXX-0176546-1/2/4 24-Jan-2012 61PDC11 3001617666 Apotex Inc Canada
 
112-7661717-6/1/1 12-Jan-2012 61PIA99 3005000275 Hersol Manufacturing Laboratories cc South Africa
 
AEK-8390027-0/5/3 06-Jan-2012 61TCA17 3009241718 Mr Madan Paul India
 
AEK-8390027-0/5/2 06-Jan-2012 61TCA26 3009241718 Mr Madan Paul India
 
AEK-0038129-9/1/3 11-Jan-2012 61TCA31 3009312402 S.M.S.C Silva Sri Lanka
 
UPS-4723566-4/1/1 11-Jan-2012 61TCA31 3009284787 Recuperacion Materiales Diversos Spain
 
U47-0489161-1/3/1 12-Jan-2012 61TCA31 3002807336 Janssen Research & Development Janssen Pharmaceutica, N.v. Belgium
 
AEK-0041087-4/7/1 17-Jan-2012 61TCA31 3005029956 Torrent Pharmaceuticals Ltd. India
 
112-6944392-9/1/1 13-Jan-2012 61TDB26 3004076521 Sun Pharmaceutical Industries, Ltd. - Silvassa India
 
112-5229824-0/2/1 04-Jan-2012 61W04 3000270594 Scheramex S A De C V Mexico
 
N90-1049305-0/8/1 12-Jan-2012 61WAJ04 3006585377 Holden Medical Laboratories India
 
UPS-3370654-6/1/1 04-Jan-2012 61WBR41 3003724330 Prosintesis S.A. de C.V. Mexico
 
XXX-0176546-1/2/32 24-Jan-2012 61WDB52 3003916517 Unipharma International, SA Guatemala
 
DZ1-0432720-7/1/2 05-Jan-2012 61WDL99 3003996590 Two Way Trading Co., Hong Kong SAR
 
XXX-0176546-1/2/23 24-Jan-2012 61WDO52 3003916517 Unipharma International, SA Guatemala
 
XXX-0176546-1/2/30 24-Jan-2012 61WDP18 3005178255 Pharmalat Guatemala
 
231-3725909-3/1/1 06-Jan-2012 61WIP99 3002806821 MSD Organon BV Netherlands
 
112-5315947-4/1/1 12-Jan-2012 61XCZ37 3009272927 Pioneer Laboratories (India Pvt India
 
M21-0745060-5/4/1 23-Jan-2012 61XDA08 3004850451 Wendt-Chemie Vertriebsges Mbh & Co. Germany
 
F23-9056206-4/1/1 13-Jan-2012 61XDZ14 3003773752 Fleming Laboratories Limited India
 
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