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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 62-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-6709462-6/1/1 05-Apr-2012 62FCQ53 3004205525 Merck S.A. Venezuela
 
109-0848756-3/2/1 03-Apr-2012 62FDR46 3007420666 Sultan Healthcare United States
 
TZ8-0909645-4/2/1/B 30-Apr-2012 62FOL17 3008221305 Medivet Pty Australia
 
ED5-0044468-9/5/1/D 19-Apr-2012 62GBU99 3007094293 Stalder Laboratiories Philippines
 
112-7889975-6/1/1 26-Apr-2012 62GCA41 3008412520 Glow Pharma Pvt Ltd India
 
112-7889975-6/2/1 26-Apr-2012 62GCA46 3008412518 Aventis Pharma Spain
 
112-7889975-6/1/2 26-Apr-2012 62GCA59 3008412519 Apex Healthcare Ltd India
 
112-6176779-7/1/1 02-Apr-2012 62GCL18 3003242976 Nuvo Manufacturing Canada
 
112-6165603-2/1/1 20-Apr-2012 62GCP82 3003612393 Wak-Chemie Medical Gmbh Germany
 
112-9228159-3/1/1 26-Apr-2012 62GDJ99 1000386375 Schering Plough Sa De Cv Mexico
 
XXX-0281695-8/1/2 02-Apr-2012 62GDY18 3004641553 Merck, S.A. de C.V. Mexico
 
XXX-0281695-8/1/4 02-Apr-2012 62GDY18 3002583778 Novartis Consumer Health S.A. Switzerland
 
112-6314573-7/1/1 13-Apr-2012 62ICK99 3004847404 Roche Switzerland
 
112-8271065-0/1/1 06-Apr-2012 62IQB99 3003563645 Catalent Pharma Solutions, LLC United States
 
523-0964515-9/1/1 05-Apr-2012 62LCS40 3003698046 Aarti Drugs Limited India
 
112-9307050-8/1/1 26-Apr-2012 62LDA37 3004909700 Medix S.A Mexico
 
112-4013878-9/1/1 20-Apr-2012 62LLK47 3009154579 Laboratorios Edo Ltda Colombia
 
144-5346649-5/5/1 17-Apr-2012 62MBJ01 3003986222 Pax-All Manufacturing Inc Canada
 
112-6778441-6/1/1 23-Apr-2012 62OCA10 1451914 Abbott Laboratories United States
 
112-9228724-4/1/7 26-Apr-2012 62OCA12 3005029956 Torrent Pharmaceuticals Ltd. India
 
112-7083834-0/1/3 27-Apr-2012 62OCA19 3002829763 Astra Zeneca Canada
 
112-6764608-6/1/1 25-Apr-2012 62OCA20 3007697790 Bristol Labs United Kingdom
 
XXX-0281671-9/1/1 02-Apr-2012 62OCY28 3004128775 Khandelwal Laboratories Ltd India
 
UPS-5645051-9/1/1 23-Apr-2012 62OCY28 3009472202 Ruben Yusep Guzman Cl Cl Colombia
 
112-6447466-4/1/3 25-Apr-2012 62ODA05 3000280957 Sandoz Canada Inc Canada
 
112-9228724-4/1/3 26-Apr-2012 62ODA14 3004132697 Cipla Ltd India
 
112-6978981-9/1/1 27-Apr-2012 62ODA14 3006947221 Pfizer Venezuela S.A. Venezuela
 
E7E-1026048-2/4/7 06-Apr-2012 62ODA39 3005793212 Sandoz Inc United States
 
112-6447466-4/1/4 25-Apr-2012 62ODA44 3000043315 Apotex Fermentation Inc. Canada
 
112-6647148-6/1/1 05-Apr-2012 62ODB05 3008918733 Sanofi Aventis Tunisia
 
E7E-1026048-2/4/17 06-Apr-2012 62ODK44 3005579246 Hospira Inc. United States
 
UPS-5804992-1/1/1 19-Apr-2012 62ODY30 1000582249 Abbott Laboratories Ltd Canada
 
112-6714934-7/1/1 30-Apr-2012 62OIY22 3000977939 F.Hoffmann -La Roche Ag Div Switzerland
 
DO7-8265041-3/1/1 06-Apr-2012 62QCK99 3000163767 Victoria-Apotheke Switzerland
 
112-2950157-7/1/3 26-Apr-2012 62SCO02 3009000028 Avalon Pharma Pvt Ltd India
 
XXX-0177610-9/1/3 09-Apr-2012 62T06 3005757050 Glenmark Pharmaceuticals Limited India
 
112-4539007-0/2/2 20-Apr-2012 62TCY06 3004006229 Glenmark Generics Limited India
 
AEK-8397782-3/1/1 03-Apr-2012 62UBA99 3009430183 Bhaskar Rao India
 
XXX-0177611-8/1/5 09-Apr-2012 62V42 3007355139 Cipla Ltd India
 
112-6828218-8/1/2 30-Apr-2012 62VAF37 3005403909 Abbott Laboratories de Mexico S.A. de C.U. Mexico
 
112-6828218-8/1/1 30-Apr-2012 62VCC32 3009390965 Glaxo Smithkline Mexico
 
112-6828218-8/1/3 30-Apr-2012 62VCC38 3009460058 Roche Syntex Of Mex Mexico
 
E7E-1026048-2/4/10 06-Apr-2012 62VDA30 3004758118 Merck & Co Inc United States
 
ED5-0044468-9/6/3 19-Apr-2012 62WBJ17 3007094293 Stalder Laboratiories Philippines
 
144-5361579-4/2/2 27-Apr-2012 62WBJ99 3002369825 DR HARRIS & CO United Kingdom
 
H32-0042973-2/8/1 13-Apr-2012 62WCJ17 3007387659 Esencias Y Perfumes Eurpoeos Mexico
 
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