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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
XXX-0177677-3/1/1/D 11-Jul-2013 60LAA01 3008007437 Unknown Multiple Countries (PODS ONLY)
 
M21-0748355-6/1/1 25-Jul-2013 60LAL21 3006094247 Research Pharmaceutical Co Ltd China
 
112-3093005-5/1/2 30-Jul-2013 60LCF34 3003909356 UCB Pharma S.A. Belgium
 
M21-0748408-3/1/1 03-Jul-2013 60LCL99 3006707356 Indo Phytochem India
 
AEK-0804325-5/1/1 11-Jul-2013 60LDA01 3008093483 Truecare Pharmaceuticals India
 
112-3223241-9/1/1 19-Jul-2013 60LIL99 3010230515 Po Sum On Ltd Hong Kong SAR
 
XXX-0177750-8/2/1 11-Jul-2013 60MCA06 3008007437 Unknown Multiple Countries (PODS ONLY)
 
336-9450862-7/1/1 30-Jul-2013 60MCH25 3003287869 Purdue Pharma Canada
 
336-9450862-7/1/4 30-Jul-2013 60MCH25 3003287869 Purdue Pharma Canada
 
336-9450862-7/1/3 30-Jul-2013 60MCH25 3003287869 Purdue Pharma Canada
 
336-9450862-7/1/6 30-Jul-2013 60MCH25 3003287869 Purdue Pharma Canada
 
336-9450862-7/1/2 30-Jul-2013 60MCH25 3003287869 Purdue Pharma Canada
 
336-9450862-7/1/7 30-Jul-2013 60MCH25 3003287869 Purdue Pharma Canada
 
336-9450862-7/1/8 30-Jul-2013 60MCH25 3003287869 Purdue Pharma Canada
 
336-9450862-7/1/9 30-Jul-2013 60MCH25 3003287869 Purdue Pharma Canada
 
336-9450862-7/1/5 30-Jul-2013 60MCH25 3003287869 Purdue Pharma Canada
 
XXX-0177645-0/2/1/A 11-Jul-2013 60MDA06 3002808221 Sophartex France
 
XXX-0176098-3/2/1 11-Jul-2013 60NDY16 1000556091 Bayer Mexico S.A. de C.V. Mexico
 
MH9-2009327-4/2/1 29-Jul-2013 60QAR46 3010070786 Hubei Province Hardware & Traffic China
 
OHL-0242792-4/1/1 01-Jul-2013 60QAS40 1545 Delta Synthetic Co. Ltd. Taiwan
 
OHL-0242792-4/2/1 01-Jul-2013 60QAS67 1545 Delta Synthetic Co. Ltd. Taiwan
 
523-0997153-0/1/1 15-Jul-2013 60QBS40 1545 Delta Synthetic Co. Ltd. Taiwan
 
UPS-1483325-7/5/2 26-Jul-2013 60QBY99 3002807757 Novocol Pharmaceutical of Canada Canada
 
WBA-9126191-6/2/1 09-Jul-2013 60QCS40 3003392295 S I M Srl Italy
 
WBA-9126191-6/1/1 09-Jul-2013 60QCS67 3003392295 S I M Srl Italy
 
UPS-4035808-1/1/1 18-Jul-2013 60QDS67 3003242976 Nuvo Manufacturing Canada
 
UPS-1483325-7/5/1 26-Jul-2013 60QDY67 3002807757 Novocol Pharmaceutical of Canada Canada
 
WO1-1098116-5/8/2 23-Jul-2013 60SBL99 3004272360 Unique Fragrances India
 
WO1-1098088-6/3/1 24-Jul-2013 60SCL99 3004254846 Baba Global Ltd India
 
M21-0748437-2/1/1 29-Jul-2013 60WAA27 3006094247 Research Pharmaceutical Co Ltd China
 
112-2898820-6/1/1 31-Jul-2013 60WDT31 3009953073 Hangzhou Minshen Binjiang Pharmaceutical Co.,Ltd China
 
112-2898804-0/1/1 01-Jul-2013 60WIZ16 3008570768 Cipla Limited India
 
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