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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
112-8800459-4/1/1 16-Sep-2009 61BCA02 3002808091 Bayer Weimar GmbH und Co. KG Germany
 
AEK-9917549-5/1/1 08-Sep-2009 61EDY04 3007730719 Cough & Chest Specialist Pte Ltd Dr Chan Tiong Beng Singapore
 
EG6-1768378-4/8/1 28-Sep-2009 61FCA56 3002808376 Apotex, Inc. Canada
 
EG6-1768659-7/7/1 28-Sep-2009 61FCA56 3002808376 Apotex, Inc. Canada
 
112-7002416-2/1/1 04-Sep-2009 61FIY54 3007486317 Pascual Laboratories Philippines
 
112-7595147-6/1/1 02-Sep-2009 61GCA84 3002807756 Teva Canada Limited Canada
 
438-0693358-6/1/1 30-Sep-2009 61HAL99 3006763819 Proandre Sl Spain
 
438-0693358-6/1/2 30-Sep-2009 61HAL99 3006763819 Proandre Sl Spain
 
M85-0054678-2/16/1 01-Sep-2009 61HKL99 3004132410 FAB LAURYL LAB. Haiti
 
DO7-8215703-9/1/2 30-Sep-2009 61JBA08 3003835430 University Of Pretoria South Africa
 
112-8801282-9/2/1 08-Sep-2009 61JCA15 2650155 MSD International GmbH (Puerto Rico Branch) LLC United States
 
DO7-8215703-9/1/1 30-Sep-2009 61LBA05 3003835430 University Of Pretoria South Africa
 
XXX-0209395-4/1/3 11-Sep-2009 61LCA38 3005095116 Laboratorio Franco Columbian Colombia
 
112-8591617-0/1/1 08-Sep-2009 61LDY14 3007147010 Les Entreprises Solumed Inc Canada
 
DO7-8215703-9/1/5 30-Sep-2009 61MBA40 3003835430 University Of Pretoria South Africa
 
AEK-9915281-7/1/4 02-Sep-2009 61MCA06 3007725874 Pro Eye Protection World P Ltd India
 
EG6-1768378-4/2/1 28-Sep-2009 61MCA38 3002808376 Apotex, Inc. Canada
 
EG6-1768659-7/3/1 28-Sep-2009 61MCA38 3002808376 Apotex, Inc. Canada
 
396-0156740-5/9/1 30-Sep-2009 61NAB74 3007844890 Shalaks Pharmaceuticals Pvt Ltd India
 
EG6-1767503-8/4/1 28-Sep-2009 61NCA05 3002808376 Apotex, Inc. Canada
 
EG6-1768658-9/9/1 28-Sep-2009 61NCA69 3002808376 Apotex, Inc. Canada
 
EG6-1768658-9/10/1 28-Sep-2009 61NCA73 3002808376 Apotex, Inc. Canada
 
EG6-1768378-4/6/1 28-Sep-2009 61NCE37 3002808376 Apotex, Inc. Canada
 
EG6-1768659-7/9/1 28-Sep-2009 61NCE37 3002808376 Apotex, Inc. Canada
 
EG6-1768454-3/5/1 28-Sep-2009 61NCE69 3002808376 Apotex, Inc. Canada
 
112-7527238-6/2/1 03-Sep-2009 61NDA66 3004978896 Laboratorios Giempi Latrinidad Venezuela
 
112-7435654-5/1/1 03-Sep-2009 61NDA80 3004393730 Pfizer, Inc. United States
 
AEK-9912339-6/1/2 02-Sep-2009 61PCA31 3007650209 Emc Brucargo Belgium
 
EG6-1768378-4/1/1 28-Sep-2009 61PCA55 3002808376 Apotex, Inc. Canada
 
EG6-1768378-4/4/1 28-Sep-2009 61PCA55 3002808376 Apotex, Inc. Canada
 
EG6-1768425-3/2/1 28-Sep-2009 61PCA55 3002808376 Apotex, Inc. Canada
 
AEK-9912339-6/1/1 02-Sep-2009 61PCA99 3007650209 Emc Brucargo Belgium
 
EG6-1768425-3/4/1 28-Sep-2009 61PCB55 3002808376 Apotex, Inc. Canada
 
EG6-1768659-7/4/1 28-Sep-2009 61PCB55 3002808376 Apotex, Inc. Canada
 
XXX-0255386-6/1/7 11-Sep-2009 61PDK17 3000151819 Novo Nordisk A/S Denmark
 
UPS-6031071-9/1/1 28-Sep-2009 61PIY55 3007737390 Personal Saudi Arabia
 
EG6-1663920-9/1/1 01-Sep-2009 61SAY01 3004103878 Crombie Kennedy Nasmark Inc. Canada
 
EG6-1663920-9/2/1 01-Sep-2009 61SBJ01 3004103878 Crombie Kennedy Nasmark Inc. Canada
 
112-8602430-5/1/2 09-Sep-2009 61TCA99 3005029956 Torrent Pharmaceuticals Ltd. India
 
112-8751171-4/1/2 21-Sep-2009 61UCC07 3003760445 Novartis Health Philippines
 
396-0156740-5/4/1 30-Sep-2009 61WBJ47 3007844890 Shalaks Pharmaceuticals Pvt Ltd India
 
DO7-8215762-5/1/1 30-Sep-2009 61WBK99 3007728477 Dr. Jrk Shiddha Research And Pharma India
 
DO7-8215762-5/1/2 30-Sep-2009 61WBO99 3007728477 Dr. Jrk Shiddha Research And Pharma India
 
EG6-1768378-4/5/1 28-Sep-2009 61XCA45 3002808376 Apotex, Inc. Canada
 
112-8751171-4/1/1 21-Sep-2009 61XCB09 3001229217 Zuellig Pharma Corporation Philippines
 
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