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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 62-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
XXX-0148571-4/1/1 28-Sep-2006 62CCA68 3003282622 Daiichi Sankyo Europe GmbH Germany
 
112-2381796-8/1/1 11-Sep-2006 62CCA99 3005807922 Tito Durand Peru
 
AEK-7129048-6/1/1 28-Sep-2006 62CCA99 3005858638 Hospital Notre Dame Lebanon
 
AEK-7129048-6/1/2 28-Sep-2006 62CCA99 3005858638 Hospital Notre Dame Lebanon
 
470-0050770-8/1/1 05-Sep-2006 62CCS65 3002806937 Esteve Quimica, S.A. Spain
 
112-2276721-4/1/1 11-Sep-2006 62DQL02 3002807086 GlaxoSmithKline Inc. Canada
 
K14-0131089-7/3/1 01-Sep-2006 62FAR34 3003695552 Jnc Nutrachem Inc. China
 
110-5463132-4/1/1 25-Sep-2006 62GAA41 3004174480 Losan Pharma GmbH Germany
 
112-2957114-8/1/1 01-Sep-2006 62GAB90 3004643567 Novartis Sverige Ab Sweden
 
AD3-0228872-6/9/1 08-Sep-2006 62GAY41 3003747886 Shanghai Dayue International China
 
442-6302206-1/1/1 25-Sep-2006 62GAZ10 1000177242 Hong Mao Biochemicals Company Ltd Thailand
 
112-2957114-8/1/2 01-Sep-2006 62GBO18 3003525500 Novartis Ag Pharma Switzerland
 
112-2957114-8/1/3 01-Sep-2006 62GBO90 3003525500 Novartis Ag Pharma Switzerland
 
112-2916195-7/1/1/B 13-Sep-2006 62GCA48 3004026740 Pascual Laboratories Inc. Philippines
 
112-2916195-7/1/1/A 13-Sep-2006 62GCB48 3003621956 United Laboratories Inc Philippines
 
336-2663199-1/1/1 01-Sep-2006 62GCS46 1000263197 Southwest Pharmaceutical China
 
DO7-0105244-4/1/1 22-Sep-2006 62GDB99 3005874745 Lorena Ferreira Rocha Brazil
 
417-0238067-0/1/2 19-Sep-2006 62GDL99 3003230328 Pahang Pharmacy Sdn Bhd. Malaysia
 
112-2550186-7/1/1 20-Sep-2006 62GQA88 3003222551 Ceva Sante Animale France
 
AEK-7132821-1/1/4 29-Sep-2006 62ICP99 3003756089 Runge Pharma Germany
 
336-2883943-6/1/1 19-Sep-2006 62ICS24 3002808211 Olon S.p.A. Italy
 
K14-0130777-8/37/1 08-Sep-2006 62JAS09 3005819909 Chengdu Superman Plant & Chemical D China
 
AEK-7127490-2/1/1 06-Sep-2006 62LBY99 3005846349 Esther Omakun Nigeria
 
110-5592524-6/1/1 14-Sep-2006 62MDO09 3005525858 Cuticura Laboratories Inc Canada
 
DO7-0108159-1/1/1 05-Sep-2006 62NCO99 3005826729 Aum International India
 
AEK-7124797-3/2/3 05-Sep-2006 62OCA05 3005828290 Niksun India Pvt India
 
112-3187124-7/3/1 19-Sep-2006 62OCB03 3005900877 Les Laboratoires Servier Industr India
 
112-2957316-9/8/1 01-Sep-2006 62OCP03 3004055168 Les Laboratories Servier Industrie France
 
112-2957316-9/4/1 01-Sep-2006 62OCP14 3003382089 Pfizer Ireland Pharmaceuticals Ireland
 
XXX-0148465-9/1/1 08-Sep-2006 62OCY22 3001056209 unknown India
 
112-2635969-5/1/1 06-Sep-2006 62ODA32 3005838415 New Smart Formulae Philippines
 
112-2662894-1/1/1 20-Sep-2006 62ODB44 3004476143 Novartis Pharma Netherlands
 
XXX-0242976-0/1/1 29-Sep-2006 62QDA99 3003396274 Novartis Pharma Ag Sweden
 
XXX-0242976-0/1/2 29-Sep-2006 62QDA99 3003396274 Novartis Pharma Ag Sweden
 
110-5762556-2/1/3 28-Sep-2006 62SCJ02 3005882375 Basant Exports India
 
110-5569308-3/1/1 14-Sep-2006 62TCA02 3005850648 Jenifer Pacheco Honduras
 
110-5706837-5/1/1 20-Sep-2006 62TCA02 3003147661 Muthu Pharmacy India
 
110-5735778-6/1/1 20-Sep-2006 62TCA02 3003147661 Muthu Pharmacy India
 
110-5695263-7/1/2/A 20-Sep-2006 62TCA07 3003147661 Muthu Pharmacy India
 
110-5696526-6/1/1 20-Sep-2006 62TCA07 3003147661 Muthu Pharmacy India
 
112-2663974-0/1/1 20-Sep-2006 62UCA08 3000183414 Janssen Ortho Canada
 
555-0469790-9/6/1 30-Sep-2006 62UCL20 3004802039 PFC INC. CO., LTD. Thailand
 
XXX-0148585-4/1/1 11-Sep-2006 62URL99 3004103905 Dominion Veterinary Laboratories Ltd. Canada
 
112-3130912-3/1/1 29-Sep-2006 62VCA99 3003262904 Glaxo Operations UK Limited United Kingdom
 
112-3130912-3/1/2 29-Sep-2006 62VCA99 3003262904 Glaxo Operations UK Limited United Kingdom
 
F02-1142876-2/1/1 08-Sep-2006 62VIY99 3003971556 Synergetica Changzhou Ltd China
 
DP4-0364811-7/1/1 20-Sep-2006 62WAY17 1513606 KAO USA Inc United States
 
DP4-0364811-7/1/2 20-Sep-2006 62WAY17 1513606 KAO USA Inc United States
 
DP4-0364811-7/1/3 20-Sep-2006 62WAY17 1513606 KAO USA Inc United States
 
218-1022001-8/1/1 13-Sep-2006 62WBJ99 3007070719 Suave Y Facil Sa De Cv Mexico
 
AUL-0065485-3/11/1 19-Sep-2006 62WBY99 1000181115 Trichema AG Switzerland
 
112-2890080-1/1/1 01-Sep-2006 62WCY09 1000623913 Braun Medical S.A. France
 
KM6-0027921-0/21/1 20-Sep-2006 62WOU16 3009892974 Thai World Import&Export Co., Ltd Thailand
 
112-2957316-9/2/1 01-Sep-2006 62YCP07 3002793686 Merck Frosst Canad Canada
 
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