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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
071-0190862-7/6/25 22-Feb-2012 64HDL01 3004624702 Poznanskie Zaklady Zielarskie Herbapol Sa Poland
 
071-0190862-7/6/26 22-Feb-2012 64HDL01 3004624702 Poznanskie Zaklady Zielarskie Herbapol Sa Poland
 
TZ8-0908744-6/1/1 29-Feb-2012 64HPY99 3008221305 Medivet Pty Australia
 
TZ8-0908744-6/1/2 29-Feb-2012 64HPY99 3008221305 Medivet Pty Australia
 
144-4159553-7/5/1/A 21-Feb-2012 64JCY99 3003793857 Zhejiang Yiwu China Small China
 
112-4064145-1/17/1 21-Feb-2012 64LAA50 3009133765 Marching Pharmaceutical Ltd Hong Kong SAR
 
820-4534093-0/1/1 17-Feb-2012 64LAS37 1000189256 Yangzhou Pharmaceutical Co., Ltd China
 
820-4532939-6/1/1 28-Feb-2012 64LAS37 3002808153 Shandong Xinhua Pharmaceutical Co., Ltd. China
 
224-3251329-3/1/1 15-Feb-2012 64LIS27 3002806965 Farmabios, S.p.A. Italy
 
112-6095405-7/1/3 22-Feb-2012 64MCA11 3002270322 Vetter Pharma Fertigung Gmbh & Co. KG Germany
 
112-6095405-7/1/4 22-Feb-2012 64MCA12 3002806979 Ferring GmbH Germany
 
AEK-8393452-7/1/1 10-Feb-2012 64RCA17 3009313631 Mazur Portugal
 
112-4064145-1/16/1 21-Feb-2012 64UBA05 3003855203 Glaxosmithkline United Kingdom
 
112-4064145-1/18/1 21-Feb-2012 64UDB06 3004110321 Merck Sharp & Dohme (Australia) Pty Ltd Australia
 
231-3735956-2/1/1 10-Feb-2012 64XAL06 3003603433 Reckitt Benckiser France
 
112-4064145-1/12/1 21-Feb-2012 64XAO07 1000304254 Stiefel Laboratories (Pte) Ltd. Singapore
 
071-0190862-7/5/11 22-Feb-2012 64XBA06 3004624702 Poznanskie Zaklady Zielarskie Herbapol Sa Poland
 
XXX-0208394-8/1/1 02-Feb-2012 64XCA11 3002806702 Cipla, Ltd. India
 
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