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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
EL0-0224017-3/16/1 05-Sep-2008 64AAL99 3003452796 Reckitt Benckiser India
 
EL0-0224017-3/17/1 05-Sep-2008 64AAL99 3003452796 Reckitt Benckiser India
 
EL0-0224017-3/18/1 05-Sep-2008 64AAL99 3003452796 Reckitt Benckiser India
 
AEK-9533847-7/1/1 02-Sep-2008 64BCA24 3007041622 Rose Janzen Canada
 
AEK-9533847-7/1/7 02-Sep-2008 64BCA24 3007041622 Rose Janzen Canada
 
112-2552968-7/1/1 30-Sep-2008 64GCC13 3005434179 Schering Plough Spain
 
112-3959288-7/1/1 03-Sep-2008 64GDA19 3005343150 Berlex Laboratories Inc United States
 
XXX-0150851-5/1/2 09-Sep-2008 64GDK07 3004132792 EMS Ind. Farm. Ltda Rod SP 101 Brazil
 
112-4018915-2/1/1 08-Sep-2008 64LAO03 3004705724 Leo Pharma Inc Canada
 
XXX-0155117-6/1/1/A 12-Sep-2008 64LCJ03 3003475851 Vinco Corporation Italy
 
XXX-0155117-6/1/1/H 12-Sep-2008 64LCJ03 3007018612 Labo. DERMA France
 
112-4018696-8/1/3 10-Sep-2008 64LDA06 3005512930 Memphis Pharma Egypt
 
112-3780528-1/1/2 03-Sep-2008 64LDB06 1000176409 Schering Plough France
 
XXX-0155117-6/1/1/B 12-Sep-2008 64LDJ45 3003484865 Pharmcia Corp Canada
 
802-0022664-7/2/1 29-Sep-2008 64NCA04 3002806439 Pfizer Canada Inc. Canada
 
AEK-9533847-7/1/10 02-Sep-2008 64NCA05 3007041622 Rose Janzen Canada
 
112-4257019-3/2/1 19-Sep-2008 64NDP05 3001292976 Novartis Consumer Health United Kingdom
 
XXX-0155459-2/1/1/A 17-Sep-2008 64XDR06 3006742008 Copac Nigeria ltd Nigeria
 
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