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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-2347537-5/1/1 01-Jun-2011 60DCA03 3008921919 Saulo Cuevas Hernandez Mexico
 
UPS-2413535-8/1/5 16-Jun-2011 60LAA05 3008938242 William Parra Paredes Colombia
 
XXX-0174022-5/1/1 30-Jun-2011 60LAY01 1000467881 Laboratorios Lamfer, S.A. Guatemala
 
XXX-0174022-5/1/12 30-Jun-2011 60LAY01 1000536663 Bayer De Guatemala S.A. Guatemala
 
XXX-0174022-5/1/15 30-Jun-2011 60LAY01 3010221253 LABORATORIOS LOPEZ, S.A DE C.V. El Salvador
 
XXX-0174022-5/1/21 30-Jun-2011 60LAY01 3003339540 Unipharm S.A Guatemala
 
XXX-0174022-5/1/30 30-Jun-2011 60LAY01 3010221253 LABORATORIOS LOPEZ, S.A DE C.V. El Salvador
 
AEK-8747505-5/1/1 09-Jun-2011 60LBA69 3008919927 George Nagiub Egypt
 
XXX-0266930-8/1/4 14-Jun-2011 60LBY01 3005355215 Laboratorios Lamfer Guatemala
 
M21-0743758-6/1/1 24-Jun-2011 60LCA01 3006094247 Research Pharmaceutical Co Ltd China
 
AEK-8374680-6/2/1 02-Jun-2011 60LCA05 3008892828 Rubina Khan India
 
XXX-0174022-5/1/16 30-Jun-2011 60LDY05 1000536663 Bayer De Guatemala S.A. Guatemala
 
XXX-0174022-5/1/20 30-Jun-2011 60LDY05 3001027464 UNKNOWN Guatemala
 
XXX-0174022-5/1/32 30-Jun-2011 60LDY21 3006296622 Sanofi Aventis De Mexico Sa De Cv Mexico
 
UPS-2327496-8/9/1 03-Jun-2011 60QAL67 3003746981 Canadian College Of Holistic Health Canada
 
UPS-2327496-8/9/2 03-Jun-2011 60QAL67 3003746981 Canadian College Of Holistic Health Canada
 
300-3788328-5/56/1 10-Jun-2011 60QAL69 1450238 Combe Laboratories, Inc. United States
 
UPS-2327496-8/4/1 03-Jun-2011 60QAL78 3003228982 Alcon Canada Inc Canada
 
322-0488425-2/1/1 02-Jun-2011 60QAZ99 3004787164 Vigor (China) Products China
 
300-3788328-5/55/1 10-Jun-2011 60QBL56 1450238 Combe Laboratories, Inc. United States
 
300-3788328-5/50/1 10-Jun-2011 60QBL56 1450238 Combe Laboratories, Inc. United States
 
300-3788328-5/52/1 10-Jun-2011 60QBL56 1450238 Combe Laboratories, Inc. United States
 
300-3788328-5/54/1 10-Jun-2011 60QBL56 1450238 Combe Laboratories, Inc. United States
 
300-3788328-5/51/1 10-Jun-2011 60QBL56 1450238 Combe Laboratories, Inc. United States
 
300-3788328-5/57/1 10-Jun-2011 60QBL56 3005599909 Combe Inc Canada
 
300-3788328-5/53/1 10-Jun-2011 60QBR56 1450238 Combe Laboratories, Inc. United States
 
XXX-0174022-5/1/19 30-Jun-2011 60QDY56 3005463909 Laboratorios Unidos Guatemala
 
XXX-0266930-8/1/3 14-Jun-2011 60SAY13 3008708667 Laboratorio Therfam S.A.O Guatemala
 
112-1880396-8/4/1 22-Jun-2011 60WCS39 3007924491 Nortec Quimica S A Brazil
 
XXX-0174022-5/1/2 30-Jun-2011 60WDY16 3010221253 LABORATORIOS LOPEZ, S.A DE C.V. El Salvador
 
XXX-0174022-5/1/23 30-Jun-2011 60WDY16 3004740219 Laboratorios Therfam Guatemala
 
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