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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 60-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
UPS-0165435-7/1/1/G 13-Mar-2008 60CCC57 3006685116 Unaiza Rana Canada
 
UPS-0165435-7/1/1/H 13-Mar-2008 60CCC57 3006685116 Unaiza Rana Canada
 
336-7497169-5/1/2 04-Mar-2008 60CCS32 3007692005 Boehringer Ingelheim Pharma GMBH & Co Germany
 
XXX-0151902-5/1/2 13-Mar-2008 60IBA99 3004122537 Laboratorios Quirarma, S.A. Guatemala
 
336-7133163-8/1/1 17-Mar-2008 60LAQ99 3005799165 Colepccl Rapid Spray Gmbh Germany
 
336-7133163-8/2/1 17-Mar-2008 60LAQ99 3005997709 MedPharm R&D Centre United Kingdom
 
112-1775592-8/1/1 26-Mar-2008 60LAY05 3006717458 Dersan Pharmaceutical Co. Ltd. Philippines
 
112-1775592-8/1/2 26-Mar-2008 60LAY05 3006717459 Hisamitsu Pharmacuetical Co. Inc Philippines
 
112-0137960-2/1/1 10-Mar-2008 60LBB01 3006545376 Sterling Products Indonesia
 
UPS-0330126-2/1/3 25-Mar-2008 60LCA01 3006213127 Pak Mail De Occidente Sa De Cv Mexico
 
UPS-0013721-4/1/3 06-Mar-2008 60LCA14 3001743983 Novartis Farmaceutica S.A. De C.V. Mexico
 
AEK-7749384-5/2/18 28-Mar-2008 60LCC85 3002106632 Global Rx Inc United States
 
XXX-0151423-2/1/6 13-Mar-2008 60LDA01 3005203073 Bayer S.A. Guatemala
 
XXX-0151423-2/1/7 13-Mar-2008 60LDA01 3005286078 Pfizer Colombia
 
XXX-0151423-2/1/8 13-Mar-2008 60LDA01 3005529211 Donovan Werke A.G.S.A. International Guatemala
 
XXX-0151423-2/1/10 13-Mar-2008 60LDA01 3004565999 Drogueria Roland Louis Guatemala
 
XXX-0151423-2/1/11 13-Mar-2008 60LDA01 3006335737 Fortepsa Guatemala
 
XXX-0151423-2/1/12 13-Mar-2008 60LDA01 3006335737 Fortepsa Guatemala
 
XXX-0151423-2/1/13 13-Mar-2008 60LDA01 3003916517 Unipharma International, SA Guatemala
 
XXX-0151423-2/1/14 13-Mar-2008 60LDA01 3004565999 Drogueria Roland Louis Guatemala
 
XXX-0151441-4/1/4 13-Mar-2008 60LDA05 3003724366 Glaxo Smith Kline Panama S.A. Panama
 
XXX-0151441-4/1/5 13-Mar-2008 60LDA05 3003724366 Glaxo Smith Kline Panama S.A. Panama
 
XXX-0248592-9/1/2 11-Mar-2008 60LDB01 3004103737 Laboratorios Terapeuticos Medicinales El Salvador
 
UPS-0146857-6/1/2 13-Mar-2008 60LDM01 3000223220 Industria Farmaceutica Andromaco S.A. de C.V. Mexico
 
XXX-0151441-4/1/10 13-Mar-2008 60LDY99 1000200056 Procter & Gamble De Mexico S.A. Mexico
 
112-1657227-4/1/1 13-Mar-2008 60MIY28 1000513229 Alkermes, Inc. United States
 
UPS-0311319-6/1/1 21-Mar-2008 60NCA03 3006705889 Hi-Tech Pharmaceutical United States
 
112-1482654-0/1/1 19-Mar-2008 60NRO14 3006260756 Customized Health Solns Singapore
 
UPS-0426486-5/3/1 24-Mar-2008 60QBL67 2016565 Unit Dose Packaging Inc United States
 
UPS-0426486-5/4/1 24-Mar-2008 60QBL67 3004069985 Bella Co. Ltd. Taiwan
 
UPS-0426486-5/5/1 24-Mar-2008 60QBL67 3004069985 Bella Co. Ltd. Taiwan
 
112-1722117-8/1/1 28-Mar-2008 60QCY86 3005982370 Astrazeneca Farmaceutica Spain
 
XXX-0151902-5/1/1/A 13-Mar-2008 60SBA99 3004122537 Laboratorios Quirarma, S.A. Guatemala
 
J61-0020833-5/3/1 13-Mar-2008 60SBY99 3006598128 Commerciale Ragozzino Srl Italy
 
J61-0020833-5/11/1 13-Mar-2008 60SBY99 3006598128 Commerciale Ragozzino Srl Italy
 
M21-0737408-6/4/1 07-Mar-2008 60SCA23 3004850451 Wendt-Chemie Vertriebsges Mbh & Co. Germany
 
UPS-0165435-7/1/1/I 13-Mar-2008 60XCC17 3006685116 Unaiza Rana Canada
 
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