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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 65-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-2441278-8/1/51 11-Sep-2012 65FIK99 3005579246 Hospira Inc. United States
 
112-2441278-8/1/53 11-Sep-2012 65FIK99 3005579246 Hospira Inc. United States
 
112-2441278-8/1/58 11-Sep-2012 65FIK99 3005579246 Hospira Inc. United States
 
112-2441278-8/1/52 11-Sep-2012 65FIK99 3005579246 Hospira Inc. United States
 
KL1-0169552-8/1/1 07-Sep-2012 65GAK99 3003569504 Jabones Pardo S.A. Spain
 
KL1-0169552-8/2/1 07-Sep-2012 65GAK99 3003569504 Jabones Pardo S.A. Spain
 
AEK-0476097-7/1/1 14-Sep-2012 65GAY99 3009676551 Shenzhen Valuelink Technology Co Ltd China
 
KL1-0172226-4/1/1 18-Sep-2012 65GBO99 3003569504 Jabones Pardo S.A. Spain
 
112-9146408-4/1/1 17-Sep-2012 65HIY01 3002807874 Pharmacosmos A/S Denmark
 
112-2441278-8/1/32 11-Sep-2012 65QCA60 2431855 Pliva Inc United States
 
112-9036843-5/1/1 25-Sep-2012 65QCK64 3002608066 Fresenius Kabi Norge As Norway
 
WQ8-0526522-7/1/1 28-Sep-2012 65QCS22 3009166025 Zhejiang Jianfeng Haizhou Pharn China
 
XXX-0224053-0/1/1 21-Sep-2012 65QCY24 3003579793 Laboratorios Vijosa S.A de C.V. El Salvador
 
112-2441278-8/1/54 11-Sep-2012 65RCK17 3005579246 Hospira Inc. United States
 
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