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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
AEK-7179622-7/1/2 24-May-2007 61ECA99 3006242924 W V Simeon Namibia
 
AEK-7179622-7/1/1 24-May-2007 61ECQ99 3006242924 W V Simeon Namibia
 
110-8205446-5/1/2 17-May-2007 61FCA54 3006047148 Adolfo Mercado Rubio Mexico
 
110-8144000-4/1/2 14-May-2007 61FCA55 3006071459 Cipla Ltd India
 
110-8316534-4/1/1 24-May-2007 61FCA56 3003473417 Laboratorios Senosian Mexico
 
T94-0045578-6/1/1 08-May-2007 61FCS55 1000397518 Neuland Laboratories India
 
T94-0045803-8/1/1 31-May-2007 61FCS55 1000397518 Neuland Laboratories India
 
110-8265298-7/1/1 23-May-2007 61FDK54 1000125771 Alcon Research Ltd United States
 
110-8205589-2/1/2 21-May-2007 61GCA85 3006221619 Pm Empaques Y Envios Sa De Cv Mexico
 
605-4528081-4/1/1 31-May-2007 61GCS48 3004365047 Suzhou Wugan Chemical Co., Ltd. China
 
112-6062448-3/1/1/B 03-May-2007 61HAL99 3006210578 Topline International New Zealand
 
112-6053406-2/1/1/B 03-May-2007 61HAL99 3006210578 Topline International New Zealand
 
112-6053366-8/1/1/B 03-May-2007 61HAL99 3006210578 Topline International New Zealand
 
112-6053341-1/1/1/B 03-May-2007 61HAL99 3006210578 Topline International New Zealand
 
112-6052929-4/1/1/B 03-May-2007 61HAL99 3006210578 Topline International New Zealand
 
112-6043910-6/1/1/B 03-May-2007 61HAL99 3006210578 Topline International New Zealand
 
112-6043877-7/1/1/B 01-May-2007 61HBY99 3006210578 Topline International New Zealand
 
551-6252138-4/1/1 03-May-2007 61HBY99 3004891291 Martini Promotions Canada
 
551-6985811-0/1/1 03-May-2007 61HBY99 3004957015 Grand Imports & Exports China
 
112-6103844-4/1/1/B 03-May-2007 61HBY99 3006210578 Topline International New Zealand
 
AEK-7179305-9/1/1 30-May-2007 61HCA24 3006239942 R Damodaran India
 
110-8205589-2/1/4 21-May-2007 61HCE32 3006221619 Pm Empaques Y Envios Sa De Cv Mexico
 
110-8239993-6/1/1 17-May-2007 61HDA03 3002601789 Quimica Y Farmacia Sa De Cv Mexico
 
110-8285140-7/1/2 24-May-2007 61HDA24 3003238166 ARLEX DE MEXICO S.A. DE C.V. Mexico
 
110-8316534-4/1/2 24-May-2007 61HNA43 3003319427 Janssen Cilag Sa De Cv Mexico
 
110-8315655-8/1/2/D 24-May-2007 61JCA13 3006249097 Pakmail Xalostoc Mexico
 
110-8205315-2/1/2 21-May-2007 61JCA16 3000221597 Ipr Pharmaceutical Inc United States
 
112-6181004-0/1/2 10-May-2007 61JCZ12 3002806524 TEVA Pharmaceutical Works Private Ltd. Co. Hungary
 
112-6181004-0/1/1 10-May-2007 61JCZ14 3002806524 TEVA Pharmaceutical Works Private Ltd. Co. Hungary
 
112-6249325-9/1/3 10-May-2007 61KCA16 1419886 Mylan Institutional, Inc. (d.b.a. UDL Laboratories) United States
 
336-7495954-2/2/1 24-May-2007 61KCS24 3007692005 Boehringer Ingelheim Pharma GMBH & Co Germany
 
112-6262493-7/1/2 10-May-2007 61LCB13 3004951575 Bristol Myers Egypt
 
101-7417183-4/155/1 09-May-2007 61MBR11 3004390768 Metcash Export Services Pty Ltd Australia
 
112-6103846-9/1/1 14-May-2007 61MCA17 3004889340 Valeant Canada Ltd. Canada
 
AEK-7180821-2/1/2 30-May-2007 61MCA35 3006252599 J.L. Kar India
 
N77-0152764-0/1/1 22-May-2007 61MDL31 3003768979 JSC Farmak Ukraine
 
110-8329258-5/4/1 24-May-2007 61NAC69 3006246457 Katherine Ortiz Colombia
 
112-6102119-2/1/1 01-May-2007 61NAY76 3006595385 Cadila Healthcare Limited India (Zyfine) India
 
112-6142159-0/2/1 03-May-2007 61NCA66 3006236640 Farmacia De Manipulacao Brazil
 
AEK-7180752-9/1/1 30-May-2007 61NCA83 3006251784 Pharmacie De Letoile France
 
AEK-7180752-9/1/2 30-May-2007 61NCA83 3006251784 Pharmacie De Letoile France
 
112-6249325-9/1/2 10-May-2007 61NCF80 1310337 Pfizer, Inc. United States
 
112-6117005-6/1/4 02-May-2007 61NDB03 1419886 Mylan Institutional, Inc. (d.b.a. UDL Laboratories) United States
 
AEK-7179368-7/2/2 30-May-2007 61PAR99 3006240719 Der B K Bagga India
 
AEK-7179368-7/2/4 30-May-2007 61PAR99 3006240719 Der B K Bagga India
 
110-8218969-1/1/1 24-May-2007 61PCA26 3006240166 Lucila Torres Colombia
 
AEK-7176262-5/2/1 02-May-2007 61PCA99 3006215405 Suruanatryan Padhi India
 
112-6262493-7/1/3 10-May-2007 61PCB56 3004951575 Bristol Myers Egypt
 
AEK-7170984-0/1/1 30-May-2007 61PCB99 3006176693 Maruthi Medicals India
 
110-7904909-8/1/1 04-May-2007 61PDB26 3004530896 Shionogi Inc. United States
 
112-6262493-7/1/4 10-May-2007 61PDB26 3002926998 Astrazeneca R & D Molndal Sweden
 
112-6247030-7/1/1 15-May-2007 61SAL99 3003511804 Labothene Germany
 
112-6247030-7/1/4 15-May-2007 61SAL99 3003511804 Labothene Germany
 
112-5579294-9/1/1 21-May-2007 61TAA99 3005965122 Interdelta Sa Switzerland
 
AEP-0021328-1/1/1 03-May-2007 61TCY11 3009436805 Vignesh Life Science Pvt Ltd India
 
169-3174493-8/1/1 23-May-2007 61WAY46 3000126720 Hetero Drugs Limited India
 
110-8300600-1/1/1 24-May-2007 61WCA47 3006194078 Serpaprosa S.A. De C.V. / Aeroflash Mexico
 
110-8300600-1/1/2 24-May-2007 61WCA47 3006194078 Serpaprosa S.A. De C.V. / Aeroflash Mexico
 
110-8315655-8/1/2/C 24-May-2007 61WCJ18 3006249097 Pakmail Xalostoc Mexico
 
144-9747682-2/1/1 14-May-2007 61WCO04 3005051865 Prime Packaging, Inc. United States
 
112-6117780-4/2/1 02-May-2007 61WCP45 2416101 Pfizer Inc. United States
 
112-6117005-6/1/6 02-May-2007 61WDB56 1419886 Mylan Institutional, Inc. (d.b.a. UDL Laboratories) United States
 
XXX-0201377-0/1/2 14-May-2007 61WDL04 3004152490 Bayer, S.A. Venezuela
 
112-6117780-4/1/1 02-May-2007 61WDP44 1000280098 Zach System S.P.A. (Zambon Group Spa) Italy
 
J50-0085768-8/10/1 07-May-2007 61XAY99 3005246881 Norma Emerita Martinez El Salvador
 
112-6078573-0/1/4 02-May-2007 61XCB18 3006229760 Pharmalink Inc United States
 
DO7-8705573-3/1/1 23-May-2007 61XCB45 3004520113 Sun Pharmaceutical Industries Ltd India
 
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