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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
XXX-0286383-6/1/6 12-Jun-2012 61EAA08 3006127003 Caplin Point Laboratories India
 
112-7509024-4/1/2 29-Jun-2012 61ECA08 3009533397 Abena Prempeh Canada
 
112-5500307-5/1/1 20-Jun-2012 61ECA09 3004758118 Merck & Co Inc United States
 
M21-0745484-7/1/1 12-Jun-2012 61ECS99 3005144955 Chemo S.A. Lugano Branch Switzerland
 
144-5388171-9/1/1 01-Jun-2012 61FAL21 3003101044 Avmor Canada
 
112-7520632-9/1/1/D 29-Jun-2012 61FDA54 3005888278 Innovare R&D, S.A. de C.V. Mexico
 
112-5985349-2/1/1 15-Jun-2012 61FDB54 3006496827 Gemini Pharmaceuticals Ltd Nigeria
 
M21-0746175-0/1/1 28-Jun-2012 61GCR80 3003981138 Bdr Pharmaceutical International India
 
112-7507365-3/1/2/A 29-Jun-2012 61GCY79 3001074824 Titolare A.I.C.: Ravizza Farmaceutici Spa Italy
 
HK8-0053677-1/12/1 29-Jun-2012 61HBL99 3006403682 Jiangsu Province Jianerkang Medical Dressing Co. China
 
112-6659193-6/3/1 19-Jun-2012 61HCB43 3008274551 Sanofi-Aventis De Mexico Mexico
 
112-6974091-0/1/3 18-Jun-2012 61HCL99 3002806300 Albert David, Ltd. India
 
112-5793345-2/1/1 15-Jun-2012 61HDK99 1000118068 Galderma Laboratories, L.P. United States
 
112-5793345-2/2/1 15-Jun-2012 61HDK99 3008384840 Leti Laboratories Sa Spain
 
112-5762044-7/1/2 20-Jun-2012 61JAB12 3008139707 Ropson Labs Ltd Colombia
 
112-5858533-5/1/2 15-Jun-2012 61JAC15 3005111201 Schering Plough Mexico
 
112-5858533-5/1/3 15-Jun-2012 61JCA13 3004602876 Novag Infancia Sa De Cv Mexico
 
112-7129690-1/1/4 11-Jun-2012 61JCA16 3006129987 Astra Zeneca Canada
 
112-7883449-8/1/3 11-Jun-2012 61JCB08 3009471127 Hetero Labs Limited (Unit-11 India
 
9EH-0000817-9/1/8 06-Jun-2012 61JCY12 2000022025 AIM Food Manufacturing SDN BHD Malaysia
 
112-5382029-8/2/2 18-Jun-2012 61JDB08 3003985550 Pfizer Consumer Health Care Mexico, S De Rl De Cv Mexico
 
112-6989956-7/1/1 19-Jun-2012 61JDB08 3005894266 Pfizer United States
 
112-6658578-9/1/3 18-Jun-2012 61LCA38 3008275458 Cipla Ltd India
 
112-7883449-8/1/1 11-Jun-2012 61LCB38 3004872644 Mepro Pharmaceutical (P) Ltd India
 
112-7883449-8/1/4 11-Jun-2012 61LCB38 3008412002 Lupin Ltd India
 
112-6936061-0/1/1 18-Jun-2012 61LCC38 3005859407 York Pci Group Inc Canada
 
112-7482490-8/1/3/B 29-Jun-2012 61LCK29 3005753354 Sanofi Aventis United Kingdom
 
XXX-0223768-4/1/2 25-Jun-2012 61LCY14 3006602811 Laboratories Kin Spain
 
112-7185850-3/1/1 11-Jun-2012 61LCZ32 2910913 Bayer Corporation United States
 
112-6989956-7/1/2 19-Jun-2012 61LDB38 3002482550 Briston Myers Squibb United States
 
112-6991277-4/4/1 19-Jun-2012 61LDB38 3008312516 Joanna Ferrara Canada
 
112-7549511-1/1/1 19-Jun-2012 61MCA42 3007712553 Nolberto A Meza Paraguay
 
112-5551722-3/1/1 20-Jun-2012 61MCA99 3002807756 Teva Canada Limited Canada
 
112-5597607-2/1/1 20-Jun-2012 61MCB42 3005129054 Glaxosmithkline Chile Farmaceutica Ltda Chile
 
112-7178809-7/1/1 18-Jun-2012 61MCE99 3004258294 BIOCODEX (HQ) France
 
112-0626344-9/1/1 07-Jun-2012 61MIB23 3002871440 Pfizer S A De Cv Mexico
 
112-0728750-4/1/1 04-Jun-2012 61MIE99 3004258294 BIOCODEX (HQ) France
 
112-0728750-4/1/2 04-Jun-2012 61MIE99 3004258294 BIOCODEX (HQ) France
 
112-5496500-1/1/1 20-Jun-2012 61NCA03 3005648765 Merck Laboratories Colombia
 
112-7482490-8/1/3/A 29-Jun-2012 61NCA29 3005639348 Medreich United Kingdom
 
112-5833849-5/1/2 15-Jun-2012 61NCA69 3007243153 Sandoz Div Novartis Farmacuetic Mexico
 
112-7508230-8/1/1 12-Jun-2012 61NCA74 3004518474 HAB Pharmaceuticals and Research, Ltd. India
 
112-6173351-7/1/2 20-Jun-2012 61NCA78 3003967026 Pfizer Venezuela
 
112-6474219-2/1/1 19-Jun-2012 61NCB99 3008575899 Sanofi Aventis France France
 
112-0730655-1/3/1 04-Jun-2012 61NDA44 3004189767 Universal Pharm Syrian Arab Republic
 
112-7777878-8/1/1 29-Jun-2012 61NIY77 3002807086 GlaxoSmithKline Inc. Canada
 
112-7129690-1/1/1 11-Jun-2012 61PCA55 3008279984 Ratio Pharm Canada
 
112-7500186-0/1/1/D 29-Jun-2012 61PCA55 3005886410 Minapharm Pharmaceuticals Egypt
 
112-2572615-2/1/1 04-Jun-2012 61PCK17 3000151819 Novo Nordisk A/S Denmark
 
112-2572615-2/2/1 04-Jun-2012 61PCK17 3003195501 Sanofi-Aventis Deutschland GmbH Germany
 
112-9442345-8/1/1 07-Jun-2012 61PCK17 3005251200 Iba Sa Belgium
 
112-9442345-8/2/1 07-Jun-2012 61PCK17 3003609045 Spectro Lab Poland
 
112-8490011-9/1/1 06-Jun-2012 61PCY26 3002906944 Apotex Inc. Canada
 
112-0309453-2/1/2 01-Jun-2012 61PDA11 3008700518 Apotex Europe Netherlands
 
112-0309453-2/1/3 01-Jun-2012 61PDA26 3006245401 Ratiopharm Nederland B.V. Netherlands
 
112-0309453-2/1/4 01-Jun-2012 61PDA26 3006245401 Ratiopharm Nederland B.V. Netherlands
 
112-0309453-2/2/1 01-Jun-2012 61PDA62 3006937344 Takeda Global R&D Centre (Europe) United Kingdom
 
112-6993701-1/1/1 19-Jun-2012 61PDA62 3004089779 Abbott Laboratories De Chile Ltda Chile
 
112-6974091-0/1/1 18-Jun-2012 61SCJ99 3006407810 Glenmarle Pharmaceticals India
 
112-6433326-5/1/1 20-Jun-2012 61WBJ18 3008246514 Eurofarma Laboratorios Ltda Brazil
 
112-8708629-6/2/1 07-Jun-2012 61WCB52 3008503792 Rx R Us Pharmacy Canada
 
112-8168146-4/1/1/B 01-Jun-2012 61WRN28 3003256253 Merial France
 
112-8168146-4/1/1/C 01-Jun-2012 61WRN28 3003256253 Merial France
 
112-7509024-4/1/1 29-Jun-2012 61XAA99 3006705464 Schering-Plough Canada Inc Canada
 
U47-0490915-7/1/1 01-Jun-2012 61XBK42 3003768979 JSC Farmak Ukraine
 
112-6659193-6/2/1 19-Jun-2012 61XCB99 3005111201 Schering Plough Mexico
 
XXX-0238624-2/1/1 25-Jun-2012 61XCY08 3003579793 Laboratorios Vijosa S.A de C.V. El Salvador
 
XXX-0238624-2/1/3 25-Jun-2012 61XCY21 3004477088 Laboratorios COFASA El Salvador
 
112-9303831-5/1/1 07-Jun-2012 61XDA14 3008570585 Fredun Pharmaceutical Limited India
 
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