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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
EGG-0007416-4/4/1/A 11-Oct-2011 60ABJ99 3003483565 Hbc Inc Philippines
 
EGG-0007416-4/4/1/B 11-Oct-2011 60ABJ99 3003483565 Hbc Inc Philippines
 
112-3098623-7/5/1 28-Oct-2011 60CAB09 3002429165 The Glassworks Ireland
 
112-3098623-7/2/1 28-Oct-2011 60CAB09 3006979112 Spimaco Pharmaceutical Saudi Arabia
 
112-3098623-7/3/1 28-Oct-2011 60CAB09 3002429165 The Glassworks Ireland
 
112-5952659-1/3/1 28-Oct-2011 60CDK53 3002583778 Novartis Consumer Health S.A. Switzerland
 
112-9359224-5/1/1 28-Oct-2011 60LAA14 3004258294 BIOCODEX (HQ) France
 
112-9537189-5/2/1 27-Oct-2011 60LAK88 3005136050 Laboratorios California Sa Colombia
 
112-8940749-9/1/2 28-Oct-2011 60LAP99 3003002183 Interthai Pharmaceutical Manufacturing Limited Thailand
 
112-8940749-9/3/1 28-Oct-2011 60LAP99 3003695001 Hoe Pharmaceuticals Malaysia
 
112-8940749-9/1/1 28-Oct-2011 60LAP99 1000266995 Hisamitsu Pharmaceutical Co., Inc. Japan
 
112-8940749-9/2/1 28-Oct-2011 60LAP99 3000149705 Drug Houses Of Australia Pte Ltd Singapore
 
UPS-3814614-4/1/1 03-Oct-2011 60LBJ99 3009144785 Pro Rep Group Canada
 
E7A-0015172-9/2/1 04-Oct-2011 60LBJ99 3002974349 Kim Chemicals Ltd. India
 
NN1-1100705-4/1/1 03-Oct-2011 60LBY99 3009098031 Mdt Intl Sa Switzerland
 
UPS-3814614-4/1/2 03-Oct-2011 60LBY99 3003806258 Td Branded Merchandise Canada
 
CAV-0004836-3/1/1 18-Oct-2011 60LBY99 3008005502 Hyaltech Ltd United Kingdom
 
112-9700305-8/1/1 27-Oct-2011 60LCA92 3007939434 Almahdi Syrian Arab Republic
 
112-2950864-8/1/1 13-Oct-2011 60LCJ99 3004008752 St Francis Herb Farms Canada
 
112-8664586-9/1/1 27-Oct-2011 60LCY88 3006409739 Injectalia S.r.l. Italy
 
AEK-8880107-7/2/1 26-Oct-2011 60LDB17 3009140206 Laboratorios Roemmers Sa Peru
 
112-8457846-9/1/1 03-Oct-2011 60QAA40 3007277367 Pharmayect Colombia
 
M76-7260465-1/1/1/A 28-Oct-2011 60QCY56 3009108596 1217215 Alberta Ltd. Canada
 
M76-7260465-1/1/1/B 28-Oct-2011 60QCY56 3009108596 1217215 Alberta Ltd. Canada
 
M76-7260465-1/1/1/C 28-Oct-2011 60QCY56 3009108596 1217215 Alberta Ltd. Canada
 
112-9655320-2/1/1 28-Oct-2011 60QDJ07 3005462342 Laboratorios Dermatologicos Sa D Mexico
 
112-8457846-9/3/1 03-Oct-2011 60RAA19 3006076096 Farmaceutica Paraguaya S.A. Paraguay
 
112-3824620-6/1/1 18-Oct-2011 60SAA07 3008463883 Bayer Health Care Diagnostics Division United Kingdom
 
112-9267128-9/1/4 27-Oct-2011 60SBA99 3000130652 Naturally Nova Scotia Health Canada
 
568-0114693-9/5/1 25-Oct-2011 60SBY99 3004512975 Southern Drugs & Pharmaceuticals India
 
112-3172876-2/1/1/C 11-Oct-2011 60SCB27 3008316144 Jiangsu Hansoh Pharmaceutical Co., Ltd China
 
112-9857690-4/2/1 27-Oct-2011 60WLL01 3007993206 Revetmex S.A. Mexico
 
AEK-8880396-6/1/2 12-Oct-2011 60XCA17 3009141129 Famacia Cf Chavarria Costa Rica
 
112-9952586-8/2/1 27-Oct-2011 60XCA17 3002906944 Apotex Inc. Canada
 
112-8971062-9/1/1 28-Oct-2011 60XCP04 3003477170 Novartis Argentina Sa Argentina
 
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