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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-0242908-3/1/2 29-Aug-2012 61BCY04 3006448782 Laboratorios AC Farma S.A. Peru
 
AEK-0308032-8/1/1 06-Aug-2012 61EAQ99 3009630646 V.K.Gupta India
 
112-7953732-3/1/1 15-Aug-2012 61ECQ99 3004081307 Cipla Limited India
 
M21-0745639-6/1/1 21-Aug-2012 61ECS09 3004010606 Matrix Laboratories Ltd India
 
XXX-0242860-6/1/6 27-Aug-2012 61ECY06 1913298 Sanofi - Aventis US LLC United States
 
XXX-0242924-0/1/9 29-Aug-2012 61ECY08 3005385701 Unipharm (International) S.A. Guatemala
 
XXX-0243010-7/1/8 29-Aug-2012 61EDY06 3007138352 Sanofi Aventis De Mexico Sa Cv Mexico
 
XXX-0243010-7/1/31 29-Aug-2012 61FCY14 3008087131 Syntofarma Colombia
 
AEK-0310455-7/1/1 22-Aug-2012 61GCA84 3009675885 Dr Rafiq Ahmed (Mbbs Mumbai) India
 
M21-0745836-8/1/1 21-Aug-2012 61GCL80 3003981138 Bdr Pharmaceutical International India
 
109-0857538-3/1/1 01-Aug-2012 61HAL05 3003150699 Procter & Gamble Manufacturing (Thailand) Ltd. Thailand
 
109-0857538-3/1/4 01-Aug-2012 61HAL05 3003150699 Procter & Gamble Manufacturing (Thailand) Ltd. Thailand
 
109-0857538-3/1/5 01-Aug-2012 61HAL05 3003150699 Procter & Gamble Manufacturing (Thailand) Ltd. Thailand
 
109-0857538-3/1/3 01-Aug-2012 61HAL05 3003150699 Procter & Gamble Manufacturing (Thailand) Ltd. Thailand
 
109-0857538-3/1/2 01-Aug-2012 61HAL05 3003150699 Procter & Gamble Manufacturing (Thailand) Ltd. Thailand
 
144-6067721-7/1/1 16-Aug-2012 61HDJ45 3001581899 Contract Pharmaceuticals Ltd. Canada
 
112-8945642-3/1/2 15-Aug-2012 61JCA16 3004172387 Ipr Pharmaceuticals Inc United States
 
AEK-0310251-0/1/1 20-Aug-2012 61JCA99 3009671550 Bhairawnath Chs India
 
XXX-0242818-4/1/3 27-Aug-2012 61JCY12 3004399994 Laboratorio Franco Colombiano Lafrancol S.A. Colombia
 
112-8578146-9/1/3 14-Aug-2012 61JDA08 3004561553 Sun Pharmaceutical Industries, LTD India
 
AEK-0308831-3/1/1 10-Aug-2012 61JDA14 3009645958 Jakuv Jankowski United Kingdom
 
M21-0745776-6/3/1 13-Aug-2012 61KAB05 3008367099 Shanghai Trifecta Pharma Ltd. China
 
M21-0746263-4/1/1 06-Aug-2012 61LAA38 3005144955 Chemo S.A. Lugano Branch Switzerland
 
112-8466656-2/1/6 27-Aug-2012 61LBJ08 3005043162 Merz Pharmaceuticals GmbH Germany
 
112-8945642-3/1/3 15-Aug-2012 61LCA38 3009690740 Bioprist Pharmaceutical United States
 
112-8681971-4/1/1 31-Aug-2012 61MDB30 3004786430 Sanofi Aventis France
 
112-8578146-9/1/9 14-Aug-2012 61NDA23 3006781192 Acme Formulation Pyt Ltd India
 
AEK-0307085-7/1/1 01-Aug-2012 61PAY99 3008766675 Sanjivni Herbal Care India
 
112-8945642-3/4/1 15-Aug-2012 61PCA07 3009690738 Cipla Ltd Jamaica
 
112-8733756-7/1/1 09-Aug-2012 61PCA26 3002807008 Franco-Indian Laboratories India
 
AEK-0310251-0/1/4 20-Aug-2012 61PCA31 3009671550 Bhairawnath Chs India
 
AEK-0310455-7/2/2 22-Aug-2012 61PCA31 3009675885 Dr Rafiq Ahmed (Mbbs Mumbai) India
 
112-8945642-3/3/1 15-Aug-2012 61PCA62 3004464238 Dr. Reddy's Laboratories Limited India
 
XXX-0242860-6/1/5 27-Aug-2012 61PCY55 3008226274 Sanofi Aventis Colombia
 
112-8578146-9/1/7 14-Aug-2012 61PDA31 3004515884 Micro Labs Limited - Unit III India
 
112-8578146-9/1/8 14-Aug-2012 61PDA99 3008028793 Eris Lifesciences India
 
M21-0745835-0/3/1 21-Aug-2012 61TAA17 3005144955 Chemo S.A. Lugano Branch Switzerland
 
112-8060304-9/1/1 07-Aug-2012 61TDB11 3009594020 Farmacia La Nordestana Dominican Republic
 
CFX-9908780-8/2/1 21-Aug-2012 61WCO04 3009201727 Laboratorio Farsiman Honduras
 
XXX-0243010-7/1/9 29-Aug-2012 61WCY47 3007341044 Laboratorios Finlay Honduras
 
XXX-0243010-7/1/16 29-Aug-2012 61WCY47 3005414380 Laboratorios Karnel S. de R. L. Honduras
 
XXX-0243010-7/1/17 29-Aug-2012 61WCY47 3005414380 Laboratorios Karnel S. de R. L. Honduras
 
XXX-0243010-7/1/20 29-Aug-2012 61WCY47 3007341044 Laboratorios Finlay Honduras
 
XXX-0243010-7/1/30 29-Aug-2012 61WCY47 3005076800 Corporacion Bonima, S.A. El Salvador
 
XXX-0243010-7/1/23 29-Aug-2012 61WDY04 3005794246 Laboratorios Chalver De Colombia S.A Colombia
 
XXX-0242793-9/1/6 27-Aug-2012 61XCY08 3005440006 Biomep Sa De Sv Mexico
 
XXX-0242793-9/1/5 27-Aug-2012 61XCY45 3002989060 Procaps S.A. Colombia
 
M21-0745835-0/1/1 21-Aug-2012 61XDA09 3005144955 Chemo S.A. Lugano Branch Switzerland
 
XXX-0242860-6/1/3 27-Aug-2012 61XDY08 3005138136 Laboratorios Laprin, S.A. Guatemala
 
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