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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
XXX-0268245-9/1/6 01-Apr-2011 61ACA06 3007210501 Sanofi Aventis Colombia
 
XXX-0268490-1/1/2 13-Apr-2011 61ACY06 3008226274 Sanofi Aventis Colombia
 
336-6404264-8/1/1 05-Apr-2011 61CCP07 3002807173 Hikma Farmaceutica, (Portugal) S.A. Portugal
 
112-1692863-5/1/1 19-Apr-2011 61EAA08 1937280 Meridian Medical Technologies Inc., A Pfizer Company United States
 
112-1687844-2/1/1 19-Apr-2011 61EAA08 3005074824 Meridian Medical Tech United States
 
112-1693113-4/1/1 19-Apr-2011 61EAA08 1937280 Meridian Medical Technologies Inc., A Pfizer Company United States
 
112-1691440-3/1/1 19-Apr-2011 61ECA08 1937280 Meridian Medical Technologies Inc., A Pfizer Company United States
 
112-1691019-5/1/1 19-Apr-2011 61ECA08 1937280 Meridian Medical Technologies Inc., A Pfizer Company United States
 
112-1691333-0/1/1 19-Apr-2011 61ECA08 1937280 Meridian Medical Technologies Inc., A Pfizer Company United States
 
UPS-1863655-1/1/3 29-Apr-2011 61ECA08 3006091441 Farabt Corporation Saudi Arabia
 
XXX-0268872-0/1/2 21-Apr-2011 61EDA08 3006475565 Genfar Colombia
 
112-1694828-6/1/1 19-Apr-2011 61EIA08 1937280 Meridian Medical Technologies Inc., A Pfizer Company United States
 
112-1691990-7/1/1 19-Apr-2011 61EIY08 3002695895 Merck & Co., Inc. United States
 
M21-0743402-1/1/1 04-Apr-2011 61GCL80 3007522260 Lyka Bdr International Ltd India
 
F57-6078473-9/1/1 28-Apr-2011 61GDL45 3003773810 Groupe Parima Inc. Canada
 
M76-1426280-8/13/1 25-Apr-2011 61HAL99 3008800736 Camsport Canada
 
112-1398642-0/2/6 07-Apr-2011 61HCA32 3005719315 Watson Pharma Private Limited India
 
112-1398642-0/1/1 07-Apr-2011 61HCA32 3005719315 Watson Pharma Private Limited India
 
112-1398642-0/2/5 07-Apr-2011 61HCA32 3005719315 Watson Pharma Private Limited India
 
112-1398642-0/2/2 07-Apr-2011 61HCA32 3005719315 Watson Pharma Private Limited India
 
112-1398642-0/1/3 07-Apr-2011 61HCA32 3005719315 Watson Pharma Private Limited India
 
112-1398642-0/1/2 07-Apr-2011 61HCA32 3005719315 Watson Pharma Private Limited India
 
112-1398642-0/2/3 07-Apr-2011 61HCA32 3005719315 Watson Pharma Private Limited India
 
112-1398642-0/2/4 07-Apr-2011 61HCA32 3005719315 Watson Pharma Private Limited India
 
112-1398642-0/2/1 07-Apr-2011 61HCA32 3005719315 Watson Pharma Private Limited India
 
W92-0169509-0/1/3 25-Apr-2011 61JBF99 3004330002 Insung Natural Co., Ltd. Korea, Republic Of (South)
 
XXX-0268206-1/1/4 01-Apr-2011 61JCA14 3005680013 MERCK SHARP & DOHME LTD. United Kingdom
 
UPS-1763322-9/1/6 20-Apr-2011 61JCY13 3008844469 Beldi Inc Canada
 
UPS-1877899-9/1/5 05-Apr-2011 61KAA69 3008853081 Benedetto Margherita Italy
 
XXX-0270737-1/1/2 11-Apr-2011 61MBY11 3003631870 GlaxoSmithKline Costa Rica, S.A. Costa Rica
 
UPS-1763322-9/1/9 20-Apr-2011 61NCY65 3008844469 Beldi Inc Canada
 
112-1458929-8/1/1 20-Apr-2011 61NDB55 3008629447 Sansfi Synthelabs Switzerland
 
UPS-1758325-9/1/1 21-Apr-2011 61PCY31 3006070525 Sanofi-Synthelabo Otc Spa Italy
 
UPS-1887682-7/1/2 27-Apr-2011 61TCA31 3008855244 Mr.P.K. Gazdar India
 
UPS-1778031-9/1/1 13-Apr-2011 61TCY31 3002807756 Teva Canada Limited Canada
 
AEK-8717269-4/1/1 25-Apr-2011 61TCY99 3002093078 Vasudha Pharma Chem Limited India
 
AEK-8724586-2/1/1 22-Apr-2011 61TDY31 3002093078 Vasudha Pharma Chem Limited India
 
XXX-0175172-7/1/3 28-Apr-2011 61WCL43 3008819158 T M Thakore Pharmaceutical Laboratories India
 
XXX-0268872-0/1/5 21-Apr-2011 61XCA45 3005071654 Mintlab Co. S.A. Chile
 
XXX-0268490-1/1/15 13-Apr-2011 61XCY18 3003965092 Bayer Corporation Guatemala
 
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