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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 60-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
820-4507906-6/18/1 02-Dec-2010 60CBK09 3003503724 Novartis Consumer Health S.A. Switzerland
 
820-4507906-6/16/1 02-Dec-2010 60CBO09 3003503724 Novartis Consumer Health S.A. Switzerland
 
820-4507906-6/17/1 02-Dec-2010 60CCK09 3003503724 Novartis Consumer Health S.A. Switzerland
 
UPS-0488386-0/1/1 23-Dec-2010 60CCY22 3008465708 C. Braithwaite Canada
 
AV3-0023165-9/2/15 28-Dec-2010 60LBA63 2244859 Novartis Consumer Health Inc. United States
 
AV3-0023165-9/2/19 28-Dec-2010 60LBC01 2244859 Novartis Consumer Health Inc. United States
 
AV3-0023165-9/2/21 28-Dec-2010 60LBC01 2244859 Novartis Consumer Health Inc. United States
 
F23-0755346-1/1/24 30-Dec-2010 60LBJ66 3005545009 Dr Irena Eris Sa Poland
 
112-9911926-6/1/1/A 03-Dec-2010 60LBJ99 3000240072 Starcom Ag Switzerland
 
AV3-0023165-9/2/28 28-Dec-2010 60LBL01 2244859 Novartis Consumer Health Inc. United States
 
AV3-0023165-9/2/30 28-Dec-2010 60LBL01 2244859 Novartis Consumer Health Inc. United States
 
AEK-8526779-3/1/1 06-Dec-2010 60LBY99 3008583146 Idemudeme I. Umoh Nigeria
 
112-9966926-1/5/1 08-Dec-2010 60LCA05 3002806851 Dr. Reddy's Laboratories Ltd, CTO Unit 1 India
 
112-9530754-3/1/4 03-Dec-2010 60LCA88 3006736885 Glaxosmithkline United Kingdom
 
112-9530754-3/1/3 03-Dec-2010 60LCA88 3006736885 Glaxosmithkline United Kingdom
 
UPS-0282257-1/1/1 13-Dec-2010 60LCH83 3005666129 Maxima Distincion S.A De C.V Mexico
 
112-9530754-3/1/2 03-Dec-2010 60LCQ88 3006736885 Glaxosmithkline United Kingdom
 
FY1-0048529-8/1/1 15-Dec-2010 60LIY99 1000266995 Hisamitsu Pharmaceutical Co., Inc. Japan
 
600-7225787-0/1/1 03-Dec-2010 60QBL11 3005673327 Shanghai Mei Jia Jing Hotel Supplies Co., Ltd. China
 
F57-2921532-0/1/1 07-Dec-2010 60QDJ40 3003773810 Groupe Parima Inc. Canada
 
597-0162367-6/2/5 16-Dec-2010 60SBA07 3002494796 Homeo Green, Inc. Japan
 
AV3-0023165-9/2/6 28-Dec-2010 60SBL04 2244859 Novartis Consumer Health Inc. United States
 
AV3-0023165-9/2/7 28-Dec-2010 60SBL04 2244859 Novartis Consumer Health Inc. United States
 
597-0162367-6/2/3 16-Dec-2010 60SBR07 3002494796 Homeo Green, Inc. Japan
 
597-0162367-6/2/4 16-Dec-2010 60SBR07 3002494796 Homeo Green, Inc. Japan
 
BGG-5253903-4/75/1 21-Dec-2010 60SBY99 3004115258 D.B. Ramsden & Co. Ltd. United Kingdom
 
M21-0742647-2/1/1 21-Dec-2010 60WCA01 3005144955 Chemo S.A. Lugano Branch Switzerland
 
112-9305109-4/1/1 01-Dec-2010 60XCE02 3005286803 Gx International Inc Philippines
 
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