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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 63-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
XXX-0244287-0/1/15 09-Oct-2012 63BCY26 3004399994 Laboratorio Franco Colombiano Lafrancol S.A. Colombia
 
FP1-0008186-7/31/1 12-Oct-2012 63BDK22 3007250542 Cenexi France
 
FP1-0008186-7/2/1 12-Oct-2012 63BDQ02 3003461378 Ivax Pharmaceuticals Uk Limited United Kingdom
 
FP1-0008186-7/14/1 12-Oct-2012 63FCK06 3002807114 GlaxoSmithKline Manufacturing S.p.A. Italy
 
FP1-0008186-7/25/1 12-Oct-2012 63HDL20 3002960087 Martindale Pharmaceuticals United Kingdom
 
112-9036750-2/5/11 12-Oct-2012 63NBJ04 3002806462 Bayer Pharma AG Germany
 
D21-0054298-6/9/1 09-Oct-2012 63RAO05 3007313144 Capital Ventures Pvt. Ltd. India
 
KM6-0058453-6/7/1 09-Oct-2012 63RAY99 3006993135 TOHFA ENTERPRISE Bangladesh
 
BDC-0028940-2/2/1/A 15-Oct-2012 63RBY05 3008819684 Aroma Cosmetics Bulgaria
 
BDC-0028940-2/2/1/B 15-Oct-2012 63RBY05 3008819684 Aroma Cosmetics Bulgaria
 
BDC-0028940-2/2/1/D 15-Oct-2012 63RBY05 3008819684 Aroma Cosmetics Bulgaria
 
442-6256807-2/30/1 15-Oct-2012 63RBY05 3009016267 Colgate-Palmolive(Thailand) LTD. Thailand
 
KM6-0124124-3/8/1 10-Oct-2012 63RBY06 3001413302 Dabur India Limited India
 
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