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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
112-4497664-8/1/1 28-Dec-2011 61AIS06 3008569178 Fagron Services Netherlands
 
M21-0745031-6/6/1 04-Dec-2011 61EAA08 3005144955 Chemo S.A. Lugano Branch Switzerland
 
M21-0745031-6/4/1 04-Dec-2011 61EAA08 3005144955 Chemo S.A. Lugano Branch Switzerland
 
112-1244417-3/1/12 28-Dec-2011 61EAY04 3004081307 Cipla Limited India
 
112-1244417-3/1/5 28-Dec-2011 61EAY11 3004081307 Cipla Limited India
 
112-1244417-3/1/6 28-Dec-2011 61EAY11 3004081307 Cipla Limited India
 
112-1173391-5/2/1 28-Dec-2011 61ECA09 3005592058 MERCK SHARP & DOHME LIMITED United Kingdom
 
112-0645670-4/2/1 13-Dec-2011 61ECB04 3008057030 Astrazeneca Venezuela
 
112-0645670-4/9/1 13-Dec-2011 61ECB06 3005296202 Sandvik Venezuela
 
112-7799179-4/3/2 30-Dec-2011 61ECB09 3008159568 Merck Sharp & Dohme (I.A.) Corp Malaysia
 
112-0645670-4/1/1 13-Dec-2011 61ECB99 1510690 Boehringer Ingelheim Roxane Inc United States
 
112-4050395-8/1/1 28-Dec-2011 61ECQ04 2518137 AstraZeneca Pharmaceuticals LP United States
 
MA7-0689624-2/1/22 23-Dec-2011 61FAY34 3004567236 Carnival Cruise Lines Bahamas
 
XXX-0176508-1/1/2 14-Dec-2011 61FCA54 3003962366 Flamingo Pharmaceuticals Ltd. India
 
M21-0745033-2/1/1 04-Dec-2011 61FCA55 3006094247 Research Pharmaceutical Co Ltd China
 
112-8183829-5/1/1 13-Dec-2011 61FDB54 3002807060 Mylan Pharmaceuticals ULC Canada
 
112-5596451-6/1/7 13-Dec-2011 61FIY54 3008102815 Rakesh Dutt India
 
MA7-0689624-2/1/21 23-Dec-2011 61GAY85 3004567236 Carnival Cruise Lines Bahamas
 
112-1891950-9/1/1 12-Dec-2011 61GCA84 3003374081 Merk Sharp & Dohme Belgium
 
OHL-0088707-9/1/1 01-Dec-2011 61HAS45 3006630288 Zhangjiagang City Xinhui Import and Export Trading Co., Ltd. China
 
OHL-0083533-4/1/1 09-Dec-2011 61HAS45 3006630288 Zhangjiagang City Xinhui Import and Export Trading Co., Ltd. China
 
112-4735311-8/3/1 05-Dec-2011 61HBQ99 3005236255 Tristar Aromatic Perfumery Oil United Arab Emirates
 
231-7440242-2/1/1 09-Dec-2011 61JCA08 3005587313 Mylan Laboratories Limited, (Nashik FDF) India
 
231-7440242-2/6/1 09-Dec-2011 61JCA08 3005587313 Mylan Laboratories Limited, (Nashik FDF) India
 
231-7440242-2/2/1 09-Dec-2011 61JCA08 3005587313 Mylan Laboratories Limited, (Nashik FDF) India
 
231-7440242-2/3/1 09-Dec-2011 61JCA08 3005587313 Mylan Laboratories Limited, (Nashik FDF) India
 
231-7440242-2/4/1 09-Dec-2011 61JCA08 3005587313 Mylan Laboratories Limited, (Nashik FDF) India
 
231-7440242-2/5/1 09-Dec-2011 61JCA08 3005587313 Mylan Laboratories Limited, (Nashik FDF) India
 
231-7440242-2/7/1 09-Dec-2011 61JCA08 3005587313 Mylan Laboratories Limited, (Nashik FDF) India
 
231-7440242-2/8/1 09-Dec-2011 61JCA08 3005587313 Mylan Laboratories Limited, (Nashik FDF) India
 
231-7440294-3/1/1 09-Dec-2011 61JCA08 3005587313 Mylan Laboratories Limited, (Nashik FDF) India
 
112-4910374-3/1/1 09-Dec-2011 61JCA08 3000222659 Poly Expert Inc Canada
 
112-9882833-9/1/2 13-Dec-2011 61JCA14 3005416746 Blue Cross Laboratories India
 
112-2158820-0/2/1 13-Dec-2011 61JCA15 2650155 MSD International GmbH (Puerto Rico Branch) LLC United States
 
112-7799179-4/2/4 30-Dec-2011 61JCB08 3008403579 Pfizer India
 
112-7799179-4/2/3 30-Dec-2011 61JCB08 3004088394 Pfizer India
 
112-7799179-4/2/2 30-Dec-2011 61JCB08 3004088394 Pfizer India
 
112-9748188-2/1/1 13-Dec-2011 61JCY14 1000202144 Merck Sharp & Dohme Ltd United Kingdom
 
EG6-2192054-5/1/1 29-Dec-2011 61JDA08 3002906944 Apotex Inc. Canada
 
EG6-2192055-2/1/1 29-Dec-2011 61JDA08 3002906944 Apotex Inc. Canada
 
EG6-2192059-4/1/1 29-Dec-2011 61JDA08 3002906944 Apotex Inc. Canada
 
EG6-2192060-2/1/1 29-Dec-2011 61JDA08 3002906944 Apotex Inc. Canada
 
112-8183829-5/1/3 13-Dec-2011 61JDB14 3002807060 Mylan Pharmaceuticals ULC Canada
 
112-5596451-6/1/1 13-Dec-2011 61JIY99 3008102815 Rakesh Dutt India
 
112-5596451-6/1/3 13-Dec-2011 61JIY99 3008102815 Rakesh Dutt India
 
112-3928601-1/1/1 28-Dec-2011 61KIA99 3004943008 Kerala Ayurvedic Centre India
 
MA7-0689624-2/1/11 23-Dec-2011 61LAY29 3004567236 Carnival Cruise Lines Bahamas
 
112-5397331-1/7/1 13-Dec-2011 61LCA12 3002807060 Mylan Pharmaceuticals ULC Canada
 
112-7799179-4/1/2 30-Dec-2011 61LCB38 3007323459 Sanofi Aventis Tiaciari Turkey
 
112-1650672-0/1/1 16-Dec-2011 61LCL40 1610287 Alcon Research, Ltd. United States
 
112-0260793-8/1/1 30-Dec-2011 61LCP29 3008695133 Aventis United States
 
112-4779928-6/1/1 01-Dec-2011 61LCS39 3002874027 Teva Pharmaceutical Industries, LTD. Israel
 
112-4779928-6/1/2 01-Dec-2011 61LCS39 3002874027 Teva Pharmaceutical Industries, LTD. Israel
 
MA7-0689624-2/1/15 23-Dec-2011 61MAY11 3004567236 Carnival Cruise Lines Bahamas
 
112-9882833-9/1/4 13-Dec-2011 61MCA06 3004951811 Mano Pharmaceuticals India
 
112-1045760-7/1/1 27-Dec-2011 61MCA06 3005088520 Titolare Italy
 
112-1713477-9/1/1 13-Dec-2011 61MCA40 3008794875 Janssen-Silag S.p.A. Italy
 
267-0201763-8/1/1 07-Dec-2011 61MIS40 3004161218 Dishman Pharmaceuticals and Chemicals Ltd. India
 
EYD-0103444-0/1/2 16-Dec-2011 61NAH99 3008341895 Madhur Pharma Research India
 
112-0665597-4/1/1 12-Dec-2011 61NBA55 3008743378 Sanofi-Aventis Ireland
 
112-5397331-1/3/1 13-Dec-2011 61NCA73 1000204496 Genpharm Inc. Canada
 
112-5397331-1/5/1 13-Dec-2011 61NCA76 3002906944 Apotex Inc. Canada
 
112-3146577-9/1/1 12-Dec-2011 61NCA99 3000192911 Les Laboratoires Servier France
 
112-9822703-7/1/1 13-Dec-2011 61NCB66 3002807585 Mepha LLC Switzerland
 
UPS-4249455-5/1/1 08-Dec-2011 61NDA76 3009232883 Natalie Melo Dominican Republic
 
112-8015670-7/1/1 13-Dec-2011 61NDB83 3007639311 Lundbeck Ltd Ireland
 
112-5596101-7/1/1 13-Dec-2011 61NIY69 3005890633 Intas Pharmaceuticals India
 
M21-0744957-3/1/1 04-Dec-2011 61PAA11 3005144955 Chemo S.A. Lugano Branch Switzerland
 
112-9819605-9/1/1 13-Dec-2011 61PAP20 3006275823 Novo Nordisk Spa Italy
 
MA7-0689624-2/1/7 23-Dec-2011 61PAY10 3004567236 Carnival Cruise Lines Bahamas
 
112-4559041-4/1/1 27-Dec-2011 61PBE99 3009185841 Ajmera Herbals Limited India
 
112-4587432-1/1/1 27-Dec-2011 61PBE99 3009185841 Ajmera Herbals Limited India
 
112-4558094-4/1/1 27-Dec-2011 61PBE99 3009185841 Ajmera Herbals Limited India
 
112-4562892-5/1/1 27-Dec-2011 61PBE99 3009185841 Ajmera Herbals Limited India
 
112-4585462-0/1/1 27-Dec-2011 61PBE99 3009185841 Ajmera Herbals Limited India
 
112-4567042-2/1/1 27-Dec-2011 61PBE99 3009185841 Ajmera Herbals Limited India
 
112-4584697-2/1/1 27-Dec-2011 61PBE99 3009185841 Ajmera Herbals Limited India
 
112-9882833-9/1/5 13-Dec-2011 61PCA55 3007972333 Mova Pharmaceuticals Pvt Ltd India
 
112-5596101-7/1/4 13-Dec-2011 61PCA62 3004167640 Alembic Limited India
 
112-4820244-7/1/2 09-Dec-2011 61PCB99 3003388833 Ranbaxy Laboratories Limited India
 
112-4820244-7/1/1 09-Dec-2011 61PCB99 3003388833 Ranbaxy Laboratories Limited India
 
112-0645670-4/4/2 13-Dec-2011 61PCB99 3003744061 Merck Sante Sas France
 
112-0645670-4/10/2 13-Dec-2011 61PCB99 3005296202 Sandvik Venezuela
 
112-0645670-4/10/1 13-Dec-2011 61PCB99 3004780132 Laboratories Leti Venezuela
 
112-0645670-4/4/1 13-Dec-2011 61PCB99 3004055168 Les Laboratories Servier Industrie France
 
112-8183829-5/1/2 13-Dec-2011 61PDB55 3002807060 Mylan Pharmaceuticals ULC Canada
 
112-1672700-3/1/1 13-Dec-2011 61TAA99 3006759484 Mcneil Products United Kingdom
 
MA7-0689624-2/1/12 23-Dec-2011 61TAY20 3004567236 Carnival Cruise Lines Bahamas
 
112-0076414-5/1/1 30-Dec-2011 61TDA99 3005274781 Sandoz Private Limited India
 
WBA-9112214-2/1/1 12-Dec-2011 61WAS18 3002806958 FDC, Ltd. India
 
112-1478903-9/1/1 13-Dec-2011 61WCA23 1000432766 Hex Ag Germany
 
112-2779706-0/1/1 12-Dec-2011 61WDM99 3005937022 Merck France
 
112-9957357-9/1/1 13-Dec-2011 61XAB99 3007996809 Homoeo Care India
 
609-0322077-4/1/1 12-Dec-2011 61XAS08 3009195164 Pharmatec Company Ltd. Japan
 
112-0645670-4/5/1 13-Dec-2011 61XCB99 1000223973 Schering Plough Argentina
 
112-0645670-4/14/1 13-Dec-2011 61XCK42 3003134550 Valebron & Cia , C.A. Venezuela
 
112-0645670-4/15/1 13-Dec-2011 61XCK99 3008741048 Ys Lab France
 
M21-0744957-3/2/1 04-Dec-2011 61XDA09 3005144955 Chemo S.A. Lugano Branch Switzerland
 
112-5596451-6/1/8 13-Dec-2011 61XIY45 3008102815 Rakesh Dutt India
 
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