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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 60-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
BER-4082716-2/1/1 14-Aug-2012 60CCS02 3002807400 BASF PharmaChemikalien Gmbh & Co. KG Germany
 
XXX-0289719-8/1/9 10-Aug-2012 60CCY48 3003235031 MERCK-MEXICO S.A. Mexico
 
112-7556875-1/1/1/A 07-Aug-2012 60IDN12 3002862267 Dr J Hansler Germany
 
M21-0746017-4/1/1 13-Aug-2012 60LAA14 3005144955 Chemo S.A. Lugano Branch Switzerland
 
112-8345887-0/1/1 14-Aug-2012 60LAL99 3008855266 Shree Marwal Sevashram India
 
112-8578146-9/1/6 14-Aug-2012 60LBA05 3007045040 Usv Limited India
 
J89-0114832-2/3/3 02-Aug-2012 60LBJ07 3008614345 Procter & Gamble Hygiene and Health Care Ltd. India
 
M21-0746297-2/1/1 06-Aug-2012 60LCA01 3006094247 Research Pharmaceutical Co Ltd China
 
112-8945642-3/4/2 15-Aug-2012 60LCA05 3009690739 Clincare Pharmacy Jamaica
 
M21-0746112-3/3/1 21-Aug-2012 60LCL99 3007522260 Lyka Bdr International Ltd India
 
XXX-0242818-4/1/4 27-Aug-2012 60LCY01 3003724366 GlaxoSmithKline Panama S.A. Panama
 
XXX-0242860-6/1/8 27-Aug-2012 60LCY01 3007730138 GRUNENTHAL ECUATORIANA C. LTDA Ecuador
 
XXX-0242924-0/1/2 29-Aug-2012 60LCY01 3004251330 Laboratorios Francelia Honduras
 
XXX-0243010-7/1/5 29-Aug-2012 60LCY01 3003724366 GlaxoSmithKline Panama S.A. Panama
 
XXX-0243010-7/1/10 29-Aug-2012 60LCY01 3003724366 GlaxoSmithKline Panama S.A. Panama
 
XXX-0242818-4/1/1 27-Aug-2012 60LCY05 3008251123 Winthrop Pharmaceuticals Colombia
 
AEK-0307273-9/5/1 01-Aug-2012 60LDL99 3009614720 B H Trivedi United Kingdom
 
XXX-0242793-9/1/1 27-Aug-2012 60LDY21 3005019811 Laboratorio Donovan Werke A.G.S.A. International Guatemala
 
554-8425540-5/1/1 16-Aug-2012 60MY99 3007795221 Government Of India Government Opium & Alkaloid Works India
 
AEK-0306034-6/1/1 29-Aug-2012 60SAR14 3009588718 The Original Fx Magen Austria
 
M21-0745776-6/7/1 13-Aug-2012 60SCA23 3008367099 Shanghai Trifecta Pharma Ltd. China
 
AEK-0310251-0/2/1 20-Aug-2012 60SCA25 3009671550 Bhairawnath Chs India
 
XXX-0243010-7/1/39 29-Aug-2012 60SCY25 3005632939 Laboratories La Sante Colombia
 
CFX-9908780-8/1/1 21-Aug-2012 60SDK13 3007828231 Infarma Honduras
 
M21-0746421-8/1/1 03-Aug-2012 60WCA01 3006094247 Research Pharmaceutical Co Ltd China
 
112-8643088-4/2/1 10-Aug-2012 60WDL01 3009657004 Exphar Sa Belgium
 
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