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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 64-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-6026395-3/1/1 18-Jun-2012 64AAZ20 3003768909 Kumar Organic Products Ltd. India
 
112-6026395-3/1/2 18-Jun-2012 64AAZ20 3003768909 Kumar Organic Products Ltd. India
 
HG8-0137480-9/7/1 05-Jun-2012 64ABR20 3008262962 C I Importex Colombia
 
BNI-0026887-8/6/2/A 19-Jun-2012 64ABY19 3008344793 Royal Foods Ghana
 
112-9442345-8/3/1 07-Jun-2012 64ADK05 3003609045 Spectro Lab Poland
 
112-5858533-5/3/1 15-Jun-2012 64BCA27 3003342394 Astra Zeneca AB Sweden
 
112-5833849-5/1/1 15-Jun-2012 64BCA37 3007180551 Bioresearch De Mexico Sa Mexico
 
112-2882620-7/1/1 04-Jun-2012 64DBL99 3008733410 Beauty Republic Limited Hong Kong SAR
 
U47-0490915-7/5/1 01-Jun-2012 64ECA02 3008957785 Menarini von Heiden GmbH Germany
 
112-0018278-5/1/1 07-Jun-2012 64ECK99 3003623839 Genzyme Flanders N.v. Belgium
 
112-6173351-7/1/1 20-Jun-2012 64GCA14 3005192567 Schering Venezuela
 
112-6014158-9/1/1 18-Jun-2012 64GCB07 3008179793 Bayer Sa Colombia
 
112-5499455-5/2/1 19-Jun-2012 64GCH07 3005708184 Shire Biochem Inc Canada
 
112-7440143-3/1/1 20-Jun-2012 64GDA07 3008057462 Bar Pharmaceuticals United States
 
112-6890245-3/1/1 11-Jun-2012 64GDB19 3004442378 Schering Deutschland Gmbh Germany
 
112-5839434-9/1/1 20-Jun-2012 64HBA99 3004259394 The Himalaya Drug Company India
 
XXX-0178111-2/2/8 28-Jun-2012 64HBL99 3004341688 P.A. Benjamin Manufacturing Co., Ltd. Jamaica
 
XXX-0178111-2/2/7 28-Jun-2012 64HBL99 3004341688 P.A. Benjamin Manufacturing Co., Ltd. Jamaica
 
XXX-0178111-2/2/9 28-Jun-2012 64HBL99 3004341688 P.A. Benjamin Manufacturing Co., Ltd. Jamaica
 
112-6646850-7/2/2 19-Jun-2012 64HOK02 3002735231 Chinfield S.A. Argentina
 
112-6646850-7/2/1 19-Jun-2012 64HOK02 3002735231 Chinfield S.A. Argentina
 
112-6646850-7/1/1 19-Jun-2012 64HOK02 3006797227 Brovel Sa Mexico
 
322-0707772-2/1/1 21-Jun-2012 64LAK20 3000314035 Pharmacia & Upjohn Worldwide United States
 
112-7330072-7/3/1 11-Jun-2012 64LCA44 3006245401 Ratiopharm Nederland B.V. Netherlands
 
112-5595594-4/1/1/B 20-Jun-2012 64LCO03 3005661461 Glaxosmithkilne Ltd United Kingdom
 
XXX-0286383-6/1/2 12-Jun-2012 64LCO67 3008250440 Glaxosmithkline Brasil Ltda Brazil
 
112-5595594-4/1/1/A 20-Jun-2012 64LCO67 3005661461 Glaxosmithkilne Ltd United Kingdom
 
XXX-0286383-6/1/4 12-Jun-2012 64LCQ02 3005646862 Glaxosmithkline Colombia
 
112-9648810-3/2/3 01-Jun-2012 64LDJ06 3005584017 Ranbaxy Laboratories India
 
112-8708629-6/1/4 07-Jun-2012 64LDK20 3000280957 Sandoz Canada Inc Canada
 
112-0730655-1/1/1 04-Jun-2012 64LDY07 3003974846 Schering Plough Labo NV Belgium
 
112-6021260-5/1/1 15-Jun-2012 64MCA07 3002270322 Vetter Pharma Fertigung Gmbh & Co. KG Germany
 
112-6075308-7/1/1 19-Jun-2012 64MCP99 3002270322 Vetter Pharma Fertigung Gmbh & Co. KG Germany
 
112-7188293-2/1/1 08-Jun-2012 64MCZ04 1000153019 Bachem AG Switzerland
 
112-6021260-5/1/2 15-Jun-2012 64MDA11 3002270322 Vetter Pharma Fertigung Gmbh & Co. KG Germany
 
112-6021260-5/1/3 15-Jun-2012 64MDI12 3002806979 Ferring GmbH Germany
 
112-7050989-0/1/1 18-Jun-2012 64RCP17 3002806268 Astra Pharma Inc. Canada
 
112-5810528-2/1/1 15-Jun-2012 64SPK19 3006503133 Laboratorios Alpharma Sa De Cv Mexico
 
112-6974091-0/1/2 18-Jun-2012 64TCB03 3006503087 Johnson & Johnson India
 
112-5793345-2/1/3 15-Jun-2012 64TCO08 1000036852 Astellas Pharma US Inc United States
 
523-0969682-2/1/1 07-Jun-2012 64TCT03 3009283902 Changzhou Yabang-Qh Pharmachem China
 
112-7878550-1/1/1 27-Jun-2012 64TDY99 3002807919 Prime European Therapeuticals S.p.A., abbr Euticals S.p.A. Italy
 
112-5530312-9/1/1 20-Jun-2012 64TIS99 3001078616 Lonza Chemie Ag Switzerland
 
AEK-0212460-6/1/1 06-Jun-2012 64UAY06 3009557040 Daniodar Prusty India
 
112-3819568-4/1/2 04-Jun-2012 64UDA06 3008193305 Cipla India
 
112-9648810-3/2/2 01-Jun-2012 64UDJ06 3002806642 Dr. Reddy's Laboratories India
 
112-5847878-8/1/2 15-Jun-2012 64UIA02 3009332374 Bayer Sas France
 
112-5847878-8/1/1 15-Jun-2012 64UIA02 3009332374 Bayer Sas France
 
N35-0244990-2/1/1/C 25-Jun-2012 64WAY99 3004792693 Laboratoires Quinton International S.L. Spain
 
300-5651723-6/8/1 04-Jun-2012 64XAL06 1413063 Alberto Culver Co United States
 
300-5651723-6/31/1 04-Jun-2012 64XAL06 1413063 Alberto Culver Co United States
 
112-6078040-2/1/1 18-Jun-2012 64XAL06 3003454195 Servoprax Gmbh Germany
 
112-6078040-2/1/2 18-Jun-2012 64XAL06 3008193316 Melsungen Ag Opm Germany
 
112-6078040-2/2/1 18-Jun-2012 64XAL06 3008193318 Sixtem Life Srl Italy
 
112-6078040-2/3/1 18-Jun-2012 64XAL06 3008193317 Omega Tecknika Ireland
 
UPS-5356685-3/1/2 29-Jun-2012 64XAY06 3009404666 Zo Skin United States
 
112-0934566-4/1/1 04-Jun-2012 64XCA11 3004483781 Roche Colombia Colombia
 
112-0477242-5/1/1 01-Jun-2012 64XCF11 1000249433 R.P. Scherer Gmbh Germany
 
112-7305528-9/1/1/A 18-Jun-2012 64XCJ07 3003948502 Janssen Cilag S.A. De C.V. Mexico
 
112-6773527-6/1/1 14-Jun-2012 64XCY12 3007082466 Janssen-Cilag Sa De Cv Mexico
 
071-0192206-5/3/22/H 19-Jun-2012 64XDY99 3007210248 Johnson & Johnson Poland
 
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