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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 62-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
396-0156740-5/1/1 30-Sep-2009 62CAL41 3007844890 Shalaks Pharmaceuticals Pvt Ltd India
 
EG6-1768454-3/1/1 28-Sep-2009 62CCA65 3002808376 Apotex, Inc. Canada
 
EG6-1768454-3/2/1 28-Sep-2009 62CCA65 3002808376 Apotex, Inc. Canada
 
EG6-1768658-9/3/1 28-Sep-2009 62CCA65 3002808376 Apotex, Inc. Canada
 
DO7-8215791-4/1/1 30-Sep-2009 62CCB99 3007735421 Exim Bank Tanzania, United Republic Of
 
112-7554029-5/1/1 02-Sep-2009 62CDA65 3004010466 Essex Pharma Germany
 
EG6-1768658-9/8/1 28-Sep-2009 62CDA65 3002808376 Apotex, Inc. Canada
 
112-7002416-2/2/1 04-Sep-2009 62CIY99 3007486317 Pascual Laboratories Philippines
 
H77-0117975-3/1/1 17-Sep-2009 62FBL18 3007770453 Shanghai Huadelun International China
 
112-7463238-2/1/1 04-Sep-2009 62GCB18 3007545867 Comed Pharmaceuticals Limited India
 
112-7113959-7/1/1 01-Sep-2009 62GCK35 3003571292 Laboratorios L.O. Oftalmi, C.A. Venezuela
 
DO7-8214585-1/1/1 23-Sep-2009 62HCB99 3007665753 Natalia Zapata Rico Colombia
 
T94-0051387-3/1/1 23-Sep-2009 62HCS03 3003238213 Alembic Limited India
 
334-2360373-8/1/1 29-Sep-2009 62ICQ24 3005726903 Aerosol Scandinavia Ab Sweden
 
396-0156740-5/10/1 30-Sep-2009 62JBB18 3007844890 Shalaks Pharmaceuticals Pvt Ltd India
 
AEK-9774190-0/1/1/B 08-Sep-2009 62JCR09 3007738616 Hair Biological Tech Co Ltd China
 
AEK-9921462-5/1/1 01-Sep-2009 62JIS09 3007468402 Changsha Huir Biol China
 
EG6-1767503-8/1/1 28-Sep-2009 62KCF10 3002808376 Apotex, Inc. Canada
 
EG6-1768425-3/1/1 28-Sep-2009 62KCF10 3002808376 Apotex, Inc. Canada
 
EG6-1768659-7/5/1 28-Sep-2009 62KCF10 3002808376 Apotex, Inc. Canada
 
112-7477524-9/1/1 03-Sep-2009 62KIS10 3003663256 Zhejiang Xianju Pharmaceutical Co., Ltd. China
 
112-7020319-6/2/1 01-Sep-2009 62LCA40 1000118068 Galderma Laboratories, L.P. United States
 
112-7541504-3/3/1 03-Sep-2009 62LMA47 3003353304 Laboratorios Dr Coll Dominican Republic
 
WC1-7092755-0/4/1 16-Sep-2009 62MAA08 3007504598 CADBURY ADAMS MEXICO, S DE R.L. DE C.V. Mexico
 
WC1-7092755-0/4/2 16-Sep-2009 62MAA08 3007504598 CADBURY ADAMS MEXICO, S DE R.L. DE C.V. Mexico
 
WC1-7092755-0/4/3 16-Sep-2009 62MAA08 3007504598 CADBURY ADAMS MEXICO, S DE R.L. DE C.V. Mexico
 
WC1-7092755-0/4/4 16-Sep-2009 62MAA08 3007504598 CADBURY ADAMS MEXICO, S DE R.L. DE C.V. Mexico
 
WC1-7092755-0/4/5 16-Sep-2009 62MAA08 3007504598 CADBURY ADAMS MEXICO, S DE R.L. DE C.V. Mexico
 
WC1-7092755-0/4/6 16-Sep-2009 62MAA08 3007504598 CADBURY ADAMS MEXICO, S DE R.L. DE C.V. Mexico
 
D77-0476592-5/1/1 23-Sep-2009 62MAA08 1000192319 Beijing Medicine And Health China
 
AEK-9173489-3/1/1 23-Sep-2009 62MAY99 3007666258 Sidy Kantako Mali
 
734-0041871-8/1/1 04-Sep-2009 62MBJ01 3004428513 Haw Par Bros International Ltd Singapore
 
FN5-0117989-2/1/1/B 10-Sep-2009 62MBJ08 3003179061 Pro Sero Co., Ltd Taiwan
 
DO7-8215703-9/1/3 30-Sep-2009 62OBA12 3003835430 University Of Pretoria South Africa
 
112-7527238-6/1/1 03-Sep-2009 62OCA09 3002806556 Boehringer Ingelheim Pharma GmbH & Co. KG Germany
 
AEK-9915489-6/1/2 08-Sep-2009 62OCA14 3007730718 Hpl India
 
EG6-1768429-5/1/1 28-Sep-2009 62OCA22 3002808376 Apotex, Inc. Canada
 
EG6-1768429-5/2/1 28-Sep-2009 62OCA22 3002808376 Apotex, Inc. Canada
 
EG6-1767503-8/6/1 28-Sep-2009 62OCA27 3002808376 Apotex, Inc. Canada
 
EG6-1768454-3/3/1 28-Sep-2009 62OCA27 3002808376 Apotex, Inc. Canada
 
EG6-1768454-3/4/1 28-Sep-2009 62OCA27 3002808376 Apotex, Inc. Canada
 
EG6-1768658-9/2/1 28-Sep-2009 62OCA27 3002808376 Apotex, Inc. Canada
 
EG6-1768659-7/6/1 28-Sep-2009 62OCA34 3002808376 Apotex, Inc. Canada
 
AEK-9915281-7/1/1 02-Sep-2009 62OCA41 3007725874 Pro Eye Protection World P Ltd India
 
EG6-1767503-8/3/1 28-Sep-2009 62OCE10 3002808376 Apotex, Inc. Canada
 
EG6-1767503-8/2/1 28-Sep-2009 62OCF24 3002808376 Apotex, Inc. Canada
 
EG6-1767503-8/5/1 28-Sep-2009 62OCF24 3002808376 Apotex, Inc. Canada
 
EG6-1768454-3/6/1 28-Sep-2009 62OCF24 3002808376 Apotex, Inc. Canada
 
EG6-1768454-3/7/1 28-Sep-2009 62OCF24 3002808376 Apotex, Inc. Canada
 
EG6-1768658-9/4/1 28-Sep-2009 62OCF24 3002808376 Apotex, Inc. Canada
 
EG6-1768658-9/6/1 28-Sep-2009 62OCF24 3002808376 Apotex, Inc. Canada
 
336-8587644-6/1/1 28-Sep-2009 62OCS48 3002808007 Roche Ireland Limited Ireland
 
906-0312542-9/1/1 02-Sep-2009 62QQR07 3003735909 Nantong Jinghua Pharmaceutical Co., Ltd. China
 
KH5-0043949-3/1/1 28-Sep-2009 62RQS11 3004265295 Zhejiang Medicines & Health Products Import & Export Co. Ltd China
 
AEK-9915281-7/1/2 02-Sep-2009 62TCA07 3007725874 Pro Eye Protection World P Ltd India
 
XXX-0163320-6/1/3 17-Sep-2009 62UDA07 3005028802 Bouchara Recordati France
 
112-7480216-7/1/1 04-Sep-2009 62VBA45 3002408898 Hoffman-Laroche Limited Canada
 
EG6-1768658-9/1/1 28-Sep-2009 62VCA18 3002808376 Apotex, Inc. Canada
 
EG6-1768658-9/7/1 28-Sep-2009 62VCA18 3002808376 Apotex, Inc. Canada
 
112-7072854-9/1/1 01-Sep-2009 62VCO18 3001149031 Biovail Laboratories Inc United States
 
112-8573115-7/1/1 02-Sep-2009 62VCO18 3007738895 Root Chemical Pharmacy Co Ltd Taiwan
 
112-8392987-8/1/1 03-Sep-2009 62VCS99 3002807864 Pharmachem Technologies Bahamas
 
112-8907417-4/2/1 28-Sep-2009 62VDA99 3005648755 Sagar Pharmaceuticals India
 
D97-0508549-3/6/1 14-Sep-2009 62WBL17 3005444989 Boe Dominicana C X A Dominican Republic
 
EG6-1768378-4/3/1 28-Sep-2009 62YCE05 3002808376 Apotex, Inc. Canada
 
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