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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
HK8-4267628-8/1/1 13-Mar-2013 62ACK05 3004537783 ACS Dobfar Info SA Switzerland
 
HK8-4267628-8/1/2 13-Mar-2013 62ACK05 3004537783 ACS Dobfar Info SA Switzerland
 
HK8-4267628-8/1/3 13-Mar-2013 62ACK05 3004537783 ACS Dobfar Info SA Switzerland
 
HK8-4267628-8/1/4 13-Mar-2013 62ACK05 3004537783 ACS Dobfar Info SA Switzerland
 
HK8-4267628-8/1/5 13-Mar-2013 62ACK05 3004537783 ACS Dobfar Info SA Switzerland
 
HK8-4267628-8/1/6 13-Mar-2013 62ACK05 3004537783 ACS Dobfar Info SA Switzerland
 
671-0127191-3/1/1 21-Mar-2013 62BCA04 3007184570 Impax Laboratories (Taiwan) Inc. Taiwan
 
112-2032287-5/1/1 19-Mar-2013 62CAR41 3010073718 Suzhou Pharmaceuti China
 
M21-0747593-3/1/1 28-Mar-2013 62CBB10 3007195608 Ciron Drugs & Pharmaceuticals Pvt India
 
AEK-0786292-9/1/1 07-Mar-2013 62CDY04 3008937492 Zhengding Houde Health Products Co Ltd China
 
M21-0747517-2/1/1 05-Mar-2013 62FAA34 3006094247 Research Pharmaceutical Co Ltd China
 
DU7-0114360-2/12/1 15-Mar-2013 62GBJ99 3009982584 Laboratorios Dr. A. Bjarner C.A. Ecuador
 
DU7-0114360-2/13/1 15-Mar-2013 62GBJ99 3009982614 Laboratorios H.G., C.A. Ecuador
 
UPS-0067316-2/1/1 26-Mar-2013 62GBL99 3005482889 Mbi Distributing Inc United States
 
KH5-0081414-1/27/1/S 07-Mar-2013 62GCA10 1000244108 Unknown China
 
KH5-0081414-1/22/1/J 07-Mar-2013 62GCF41 3005059619 Guangzhou Wanglaoji Pharmaceutical Co. Ltd. China
 
XXX-0253792-7/1/1 08-Mar-2013 62GCY18 3010584586 LABORATORIOS VIJOSA El Salvador
 
XXX-0240078-7/1/4 21-Mar-2013 62GCY18 3002807772 Novartis Pharma AG Switzerland
 
UPS-9096701-5/2/1 04-Mar-2013 62GCY59 3009946264 Fernando Linero Colombia
 
KH5-0081414-1/22/1/L 07-Mar-2013 62GDA18 1000244108 Unknown China
 
KH5-0081414-1/27/1/U 07-Mar-2013 62GDA18 1000244108 Unknown China
 
112-1153647-5/1/1 01-Mar-2013 62ICA31 3009960423 Mercury Pharma Group Limited United Kingdom
 
315-7379473-7/3/1 29-Mar-2013 62ICS31 3000242652 Excella GmbH Germany
 
XXX-0240054-8/1/3 14-Mar-2013 62LCY40 3005783926 Gonher Farmaceutica Colombia
 
KH5-0081414-1/27/1/D 07-Mar-2013 62LDE40 3003222197 Europharm Laboratoires Co. LTD China
 
KH5-0081414-1/23/1/F 07-Mar-2013 62LDM09 3008678605 Neimenggu Fufeng Biotechnologies Co Ltd China
 
506-0742668-6/1/1 07-Mar-2013 62LDS99 3003560650 Zhejiang Medicine Co., Ltd. China
 
XXX-0240054-8/1/2 14-Mar-2013 62LDY40 3002989060 Procaps S.A. Colombia
 
KH5-0081414-1/21/1/E 07-Mar-2013 62MBJ01 1000244108 Unknown China
 
KH5-0081414-1/25/1/E 07-Mar-2013 62MBK01 1000244108 Unknown China
 
KH5-0081414-1/26/1/K 07-Mar-2013 62MBL01 3003613970 Wong To Yick Wood Lock Ointment Ltd. Hong Kong SAR
 
KH5-0081414-1/26/1/C 07-Mar-2013 62MBY01 3003704959 Guilin China Resources Tianhe Pharmaceutical Co., Ltd. China
 
112-1682970-1/1/1 12-Mar-2013 62OAY29 3003906733 Bruluart, S.A. Mexico
 
DO7-8288461-6/1/2 22-Mar-2013 62OCB16 3010031715 Plt Scientific Sdn Bhd Malaysia
 
AEK-0583935-8/1/2 04-Mar-2013 62ODA41 3009806461 New Hope Family Health Center India
 
AEK-0583935-8/1/4 04-Mar-2013 62ODA42 3009806461 New Hope Family Health Center India
 
UPS-0061829-0/1/2 13-Mar-2013 62QQY07 3002693205 Vetoquinol N.A., Inc. Canada
 
KH5-0081414-1/27/1/E 07-Mar-2013 62UDA11 1000244108 Unknown China
 
AEK-0290468-4/1/1 04-Mar-2013 62VCK31 3002807252 Merck Serono S.p.A. Italy
 
KH5-0081414-1/22/1/N 07-Mar-2013 62VDA01 3005290297 GANKANG China
 
KH5-0081414-1/22/1/R 07-Mar-2013 62VDE01 1000244108 Unknown China
 
B08-2010800-7/15/1 22-Mar-2013 62WAL99 3001350340 Clarins France
 
112-1588658-7/1/1 26-Mar-2013 62WBU03 3008624416 Purax International Gmbh Austria
 
D03-0257339-5/6/1 08-Mar-2013 62WBY99 3001576415 Isomers Laboratories Canada
 
112-1821778-0/1/1 22-Mar-2013 62ZCA04 1000153019 Bachem AG Switzerland
 
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