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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 64-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
241-8296612-7/1/1 09-Jan-2014 64AAR20 3009012685 Kumar Organic Products Limited, 100% Export Oriented Unit India
 
UPS-6701191-9/13/1 23-Jan-2014 64ABL20 3007084136 Ningbo Unichem Household Products Co Ltd. China
 
AEK-0819230-0/2/2 17-Jan-2014 64BCA48 3010535935 Mathew George India
 
799-2235103-0/1/1 31-Jan-2014 64CBL02 3008369622 Ecorganicos De Colombia S.A. Colombia
 
231-7802168-3/1/1 07-Jan-2014 64ECZ99 3004110157 Patheon Italia S.P.A. Italy
 
XXX-0203460-2/1/3 28-Jan-2014 64GCA29 3002808086 Bayer Pharma AG Germany
 
UPS-3736489-2/2/1 27-Jan-2014 64GCY07 3007700270 Bayer Healthcare Pharmaceutical Canada
 
XXX-0203460-2/1/7 28-Jan-2014 64LCA56 3006308288 Schering-Plough S.A. De C.V. Mexico
 
W69-4080230-0/1/1 24-Jan-2014 64LPR37 3002808153 Shandong Xinhua Pharmaceutical Co., Ltd. China
 
799-1831797-9/1/3 14-Jan-2014 64PCA04 3007743667 Sun Pharma Sikkim India
 
DO7-8299885-3/1/1 22-Jan-2014 64RCK99 3010331038 Yildirim Nak Ins Taah Tur Turkey
 
AEK-0818574-2/1/1 27-Jan-2014 64UAA06 3010521589 Newa Singh India
 
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