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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 61-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-5818354-4/4/1 15-Mar-2011 61EDQ04 3002806268 Astra Pharma Inc. Canada
 
KM6-0050267-8/23/1 04-Mar-2011 61FBL21 3008410022 Reckitt Benckiser Bd Ltd Bangladesh
 
KM6-0049748-1/15/1 23-Mar-2011 61FBL21 3003452796 Reckitt Benckiser India
 
KM6-0049748-1/15/2 23-Mar-2011 61FBL21 3003452796 Reckitt Benckiser India
 
KM6-0049748-1/15/3 23-Mar-2011 61FBL21 3003452796 Reckitt Benckiser India
 
AEK-8368435-3/1/1 03-Mar-2011 61FCA54 3008770193 Suriya Damaram India
 
112-0985188-5/2/1 02-Mar-2011 61JCA14 3006576762 Amherst Laboratories Philippines
 
AEK-8368824-8/1/1 10-Mar-2011 61LBB38 3008775542 Hari Soni India
 
GEO-2112231-8/1/1 10-Mar-2011 61LDK35 3002807496 Leo Pharma A/S Denmark
 
112-0682225-1/1/1 10-Mar-2011 61MCA30 3005574265 Sanofi-Aventis Australia
 
112-8931635-2/7/1 23-Mar-2011 61MCA35 3002807756 Teva Canada Limited Canada
 
AEK-8367512-0/3/1 02-Mar-2011 61MCA40 3008747671 Sanaa Saree Egypt
 
112-0682225-1/1/2 10-Mar-2011 61MCA41 3005574265 Sanofi-Aventis Australia
 
112-8582135-5/1/1 01-Mar-2011 61MDY99 3003013954 Biocodex Laboratories France
 
112-8931635-2/6/1 23-Mar-2011 61NCA29 3002906944 Apotex Inc. Canada
 
112-6755933-8/2/1 28-Mar-2011 61NCB23 3008285469 Abbott India Limited India
 
112-0510990-8/1/1 10-Mar-2011 61NCC03 2000025711 Merind ( A Wockhardt Enterprise) India
 
231-8684534-6/1/1 29-Mar-2011 61NCE66 3004956904 Alembic Pharmaceuticals Limited India
 
231-8684534-6/1/2 29-Mar-2011 61NCE66 3004956904 Alembic Pharmaceuticals Limited India
 
112-5818354-4/2/1 15-Mar-2011 61NCF69 3002628529 Pharmascience Inc. Canada
 
UPS-1419572-7/1/2 18-Mar-2011 61NCH66 3008791299 Sylvia Recaii Saint Lucia
 
UPS-1370088-1/1/1 18-Mar-2011 61NCY78 3002706446 International Logistics Freight United Kingdom
 
112-1077824-2/1/1 11-Mar-2011 61NDA83 3006170385 Laboratoires Adwya Tunisia
 
112-1011342-4/1/1 11-Mar-2011 61PCA26 3005065515 Merck Sante France
 
112-0545726-5/1/1 10-Mar-2011 61PCB26 3004205525 Merck S.A. Venezuela
 
AEK-8670646-8/1/1 15-Mar-2011 61TCA31 3008475797 Pharmplexdirect.Com United Kingdom
 
H32-0042470-9/1/1 11-Mar-2011 61TCS17 3003721773 Dandong Pharmaceutical Factory China
 
KG2-0527528-5/1/21 29-Mar-2011 61VBA01 2210396 Novartis Pharmaceuticals Corp. United States
 
KM6-0049748-1/10/1 23-Mar-2011 61VBL99 3005593764 Cheminnova Remedies Pvt. Ltd India
 
112-8953483-9/1/1/A 07-Mar-2011 61WDJ04 3002874027 Teva Pharmaceutical Industries, LTD. Israel
 
112-0369383-8/1/1 04-Mar-2011 61XCS29 3003677831 Keshava Organics Pvt. Ltd. India
 
943-9055561-6/2/1 23-Mar-2011 61XCS29 3007497376 Supriya Lifescience Ltd India
 
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