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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
112-7330403-4/2/1 13-Jan-2012 64AAL20 3008351740 Lovehoney United States
 
112-4849980-3/2/1 06-Jan-2012 64BCB25 3005343793 Teva API India Ltd. India
 
112-8389937-9/2/1 12-Jan-2012 64GCA07 2244771 Novo Nordisk Inc United States
 
112-2189956-5/1/1 07-Jan-2012 64GCB29 3002806462 Bayer Pharma AG Germany
 
112-8214396-9/2/1 12-Jan-2012 64GCB29 3002808086 Bayer Pharma AG Germany
 
112-6053116-0/3/1 31-Jan-2012 64GCY29 1000436007 Bayer Australia Ltd. Australia
 
101-9630556-8/1/1 11-Jan-2012 64GDS17 3005122933 Symbiotec Pharmalab Limited India
 
U47-0489161-1/8/1 12-Jan-2012 64HBL01 3008778853 Beringer Ingelheim Espana Spain
 
N90-1049305-0/12/1 12-Jan-2012 64LAJ38 3006585374 Galentic Pharma Pvt Ltd India
 
XXX-0176546-1/2/18 24-Jan-2012 64LDO02 3009200877 Laboratorios Menarini, SA Nicaragua
 
XXX-0176546-1/2/8 24-Jan-2012 64LDO06 3003986207 Gamma Laboratories El Salvador
 
XXX-0176546-1/2/9 24-Jan-2012 64LDO06 3004119887 Panzyma Laboratories Nicaragua
 
XXX-0176546-1/2/21 24-Jan-2012 64LDO06 3003917875 LAFAR LAB El Salvador
 
XXX-0176546-1/2/31 24-Jan-2012 64LDO19 3004119887 Panzyma Laboratories Nicaragua
 
112-8606423-7/2/1 07-Jan-2012 64LDO67 3000263379 Glaxo Smith Kline UK United Kingdom
 
XXX-0176546-1/2/22 24-Jan-2012 64LDP06 3003917875 LAFAR LAB El Salvador
 
112-9349532-5/1/1 05-Jan-2012 64UCS99 1826582 Albemarle Corporation United States
 
BUP-1535143-3/1/1 03-Jan-2012 64UIK99 3003259844 Sanofi Winthrop Industrie France
 
BUP-1535143-3/1/2 03-Jan-2012 64UIK99 3003259844 Sanofi Winthrop Industrie France
 
AV3-0024003-1/1/3 24-Jan-2012 64XBJ06 1000526880 Reckitt Benckiser Inc United States
 
112-0177587-6/1/3 06-Jan-2012 64XCA12 3008683426 Hesa Pharmaceutica India
 
322-0608936-3/2/1 03-Jan-2012 64XIL03 3008363931 Perrigo Israel Pharmaceuticals Ltd Israel
 
322-0608936-3/1/1 03-Jan-2012 64XIL03 3008363931 Perrigo Israel Pharmaceuticals Ltd Israel
 
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