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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-7035048-9/1/1 19-May-2005 61BCS04 3000126720 Hetero Drugs Limited India
 
112-6432939-2/4/1 23-May-2005 61ECY06 3004458023 Aventis Pharmaceutical France
 
112-6305609-5/1/1 04-May-2005 61FCA55 1000194719 Ranbaxy Laboratories Limited India
 
T94-0039332-6/1/1 24-May-2005 61FCS14 3005105844 Safal International Fzc United Arab Emirates
 
523-0592899-7/1/1 05-May-2005 61GDS71 3004066383 Conqing Changshou Chemical Co Ltd China
 
AEK-7029123-8/1/1 18-May-2005 61GRR20 3004253678 Buckton Scott Ltd. Wuhan Office China
 
112-6353004-0/1/2 04-May-2005 61HCA33 3005032141 Maien Adel Egypt
 
112-6878797-5/1/1 17-May-2005 61HDY99 3003712444 Glaxosmithkline Exp United Kingdom
 
AFA-0121097-5/1/1 18-May-2005 61JAY99 3004309206 SINOCHEM QINGDAO CO., LTD China
 
AEK-7036367-2/3/1 19-May-2005 61JIA08 3005075118 Therdose Pharma Pvt Ltd India
 
610-1202404-0/1/1 18-May-2005 61JIY11 3005096739 High Goal Intertrans Shejiang Corp China
 
112-6274286-9/1/1 12-May-2005 61LBA01 3002807565 Merck Frosst Canada, Ltd. Canada
 
231-3616885-6/1/1 20-May-2005 61LCP27 3002270322 Vetter Pharma Fertigung Gmbh & Co. KG Germany
 
231-3622557-3/1/1 31-May-2005 61LCP27 3002270322 Vetter Pharma Fertigung Gmbh & Co. KG Germany
 
112-6885735-6/1/1 24-May-2005 61LDY99 3005109141 Shire Us Inc. United States
 
XXX-0113117-7/1/1 26-May-2005 61MCA06 3005073399 Javier Vegas Spain
 
112-6448169-8/1/1 24-May-2005 61MCA30 3005045595 Angel Merchandising Services Ltd. Canada
 
112-6270888-6/1/4 05-May-2005 61MCA99 3004416779 Novartis Gmbh Germany
 
112-6850358-8/2/1 05-May-2005 61MCB99 3004581395 Aventis Pharma Guatemala
 
AEK-7034190-0/1/1 19-May-2005 61MCR42 3000126720 Hetero Drugs Limited India
 
KL1-0123773-5/1/1 17-May-2005 61MCZ31 3002366874 Icn Hungary Company Limited Hungary
 
112-6513249-8/1/1 26-May-2005 61NCA44 3005054888 Jennifer Park Canada
 
112-6542237-8/1/1 31-May-2005 61NCA51 3004566535 Servientrega Internacional Colombia
 
112-6332958-3/1/1 06-May-2005 61NCA80 3003651826 Poco Shipping Canada
 
112-6914287-3/1/1 24-May-2005 61NCC99 3008794875 Janssen-Silag S.p.A. Italy
 
AEK-7040584-6/1/1 25-May-2005 61NCE55 3004215803 Pharmacie Lafragette France
 
693-0504761-0/1/1 19-May-2005 61NCS60 3003340711 Fermion OY Finland
 
AEK-7034190-0/1/2 19-May-2005 61NDR83 3000126720 Hetero Drugs Limited India
 
AEK-7026329-4/1/1 04-May-2005 61PCA31 3004997131 L Thankavelu India
 
112-6878797-5/3/1 17-May-2005 61PDA99 3004459824 Servier Sa France
 
112-6879495-5/1/1 23-May-2005 61PDA99 3005108634 Lascelles Ltd Jamaica
 
112-6835885-0/4/1 11-May-2005 61PDY99 3005103222 Heson Laboratories Philippines
 
112-6835885-0/4/2 11-May-2005 61PDY99 3004472099 Les Lab Servier Ind Philippines
 
AEK-6662487-1/3/1 04-May-2005 61QCA99 3005051913 Fr De Luzuriaga Philippines
 
112-6432939-2/2/1 23-May-2005 61QCY05 3002828344 Farmacia & Upjohn Italy
 
AYG-1000479-9/33/1 03-May-2005 61WAE99 3000983574 Emsons Exports India India
 
002-6121792-1/1/1 18-May-2005 61WAY18 3003200255 Gufic Bioscience Limited India
 
AEK-7037454-7/1/1 23-May-2005 61WBK99 3005084866 Rafif Chamesseddine Lebanon
 
112-6299974-1/2/1 06-May-2005 61WCA45 3005024407 Prakash Airfreight India
 
112-6412612-9/1/2 06-May-2005 61WCJ51 3004827829 Servientrega Inter Colombia
 
112-6915528-9/1/1 31-May-2005 61WDY99 1000166369 QUINTILES Clinical Supplies United States
 
XXX-0115554-9/1/1 25-May-2005 61XCA45 3005115707 Pharmacy Rx.com India
 
112-6915676-6/1/1 11-May-2005 61XDY45 3003775180 Ucb Farchimsa Switzerland
 
AEK-7040114-2/1/1 19-May-2005 61XIS45 3002808503 Wockhardt Limited India
 
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