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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
112-2441278-8/1/24 11-Sep-2012 64ADA04 3004758118 Merck & Co Inc United States
 
112-2441278-8/1/1 11-Sep-2012 64BCK24 3005579246 Hospira Inc. United States
 
112-2441278-8/1/2 11-Sep-2012 64BCK24 3005579246 Hospira Inc. United States
 
112-2441278-8/1/60 11-Sep-2012 64BCK24 3005579246 Hospira Inc. United States
 
AEK-0312406-8/1/1 21-Sep-2012 64BDA25 3009711047 Courtenay Chemist United Kingdom
 
112-2441278-8/1/25 11-Sep-2012 64CCK02 2127022 Paddock Laboratories, LLC United States
 
UPS-7112664-9/1/1 07-Sep-2012 64GDA29 3002808091 Bayer Weimar GmbH und Co. KG Germany
 
AGT-0008925-1/1/1/D 20-Sep-2012 64LAO67 3002189947 Scanchemie Ltd. Germany
 
AGT-0008925-1/1/1/E 20-Sep-2012 64LBO06 3006528422 ELKO Org. Ltd. Switzerland
 
AGT-0008925-1/1/1/C 20-Sep-2012 64LBO67 3008491351 Esapharma Srl Italy
 
112-2441278-8/1/7 11-Sep-2012 64LCK37 1000113778 Bausch & Lomb, Inc. United States
 
112-2441278-8/1/8 11-Sep-2012 64LCK37 1000113778 Bausch & Lomb, Inc. United States
 
112-2441278-8/1/39 11-Sep-2012 64LCO28 3003092769 Teva Pharmaceuticals USA United States
 
ED5-0046189-9/5/1/A 14-Sep-2012 64LDJ08 3004985337 Regal Pharmaceuticals Ltd Kenya
 
XXX-0243228-5/1/1 18-Sep-2012 64LDY06 3006555572 Laboratorios Piersan Guatemala
 
M21-0746573-6/1/1 12-Sep-2012 64UDZ04 3003981138 Bdr Pharmaceutical International India
 
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