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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
112-7119290-3/1/1 08-May-2012 62CAY10 1000594483 American Regent Pharmaceuticals Lab United States
 
112-8866039-6/1/1 30-May-2012 62CCB99 3005306825 Aci Pharmaceutical Ltd Bangladesh
 
112-7516071-6/1/1 17-May-2012 62CCZ41 3009539257 Xingcheng Chempharm Co Ltd China
 
112-7292726-5/1/1 17-May-2012 62CDB99 3004161480 Servier Phils, Inc Philippines
 
AEK-0109200-2/1/1 17-May-2012 62CDY99 3002905175 Novartis Ltd Canada
 
N56-0019311-8/1/1/B 09-May-2012 62FBO46 3007549067 J C Udeozor & Sons Nigeria
 
112-8131678-0/1/1 31-May-2012 62GBC99 3008440431 Purica Canada
 
BOS-0039052-9/3/1 22-May-2012 62GBY99 3009407408 Nartex Laboratorios Homeopaticos S.A. de C.V. Mexico
 
112-7345029-1/2/1 17-May-2012 62GCA41 3008057462 Bar Pharmaceuticals United States
 
112-5647892-1/1/1 01-May-2012 62GCE42 3009311229 Iroko Products United Kingdom
 
UPS-6098986-6/1/1 31-May-2012 62GCK18 3009532130 Di Giacomo Antonietta Italy
 
AEK-0123127-9/3/1 11-May-2012 62GCY83 3009442284 Shenyang Dongling Pharmaceutical Co China
 
UPS-5628429-8/1/1 11-May-2012 62GDH42 3009433832 Marcela Velasco Ayala Mexico
 
M21-0745960-6/2/1 30-May-2012 62GDL18 3008367099 Shanghai Trifecta Pharma Ltd. China
 
112-6800153-9/1/1 24-May-2012 62GIH41 3002806449 Banner Pharmacaps Canada, Ltd. Canada
 
AEK-0125754-8/1/1 11-May-2012 62GIY99 3009288522 Changsha Kangrong Biological Tech Co China
 
H87-0195454-2/1/1 21-May-2012 62GPJ99 3003516557 Laboratorios Ordonez Sa De Cv Mexico
 
H87-0195454-2/1/2 21-May-2012 62GPJ99 3003516557 Laboratorios Ordonez Sa De Cv Mexico
 
H87-0195454-2/1/3 21-May-2012 62GPJ99 3003516557 Laboratorios Ordonez Sa De Cv Mexico
 
H87-0195454-2/1/4 21-May-2012 62GPJ99 3003516557 Laboratorios Ordonez Sa De Cv Mexico
 
112-6538046-4/1/2 11-May-2012 62ICA99 3009430146 Oaialive Sa De Mexico
 
112-6538046-4/1/3 11-May-2012 62ICA99 3009430146 Oaialive Sa De Mexico
 
112-6538046-4/1/1 11-May-2012 62ICA99 3009430146 Oaialive Sa De Mexico
 
112-6538046-4/1/4 11-May-2012 62ICA99 3009430146 Oaialive Sa De Mexico
 
112-0168724-6/1/1 31-May-2012 62IQA99 3003563645 Catalent Pharma Solutions, LLC United States
 
112-0168724-6/1/2 31-May-2012 62IQA99 3003563645 Catalent Pharma Solutions, LLC United States
 
112-7345029-1/1/1 17-May-2012 62KCA11 3004529241 Lupin Limited India
 
112-7342182-1/1/1 25-May-2012 62LCB40 3009514836 Farnar Lyon France
 
M50-0209983-1/1/1 04-May-2012 62MAR08 3004801358 ARORA AROMATICS PRIVATE LIMITED India
 
UPS-6127975-4/1/1 30-May-2012 62MAY08 3010165505 Bray Group Limited United Kingdom
 
U10-5120276-4/24/1 23-May-2012 62MBJ01 3008986440 SHWE Hintar Co. Thailand
 
112-8774621-2/2/1 30-May-2012 62OAY49 3008511897 Bidde Sawyer Limited India
 
XXX-0284848-0/1/10 16-May-2012 62OCY22 3009075476 Sanofi-Aventis De Colombia Colombia
 
XXX-0284848-0/1/7 16-May-2012 62OCY28 3007861661 Genfar Colombia
 
112-4822117-3/1/1 01-May-2012 62ODA18 3008403508 Mylan Sas France
 
112-7110654-9/1/1 23-May-2012 62ODB05 3009161444 Bristol Laboratories Ltd United Kingdom
 
112-9218852-5/1/1 30-May-2012 62ODE24 1913298 Sanofi - Aventis US LLC United States
 
BYA-0120787-7/6/5 10-May-2012 62SBY99 3004672062 M.M. Enterprise India
 
112-7384379-2/3/1 22-May-2012 62SBY99 3009512294 Lorigin Cosmetics United Arab Emirates
 
112-7311073-9/3/1 25-May-2012 62SBY99 3009512294 Lorigin Cosmetics United Arab Emirates
 
322-0700528-5/1/25 30-May-2012 62SDL99 3004504938 Reviderm Ag Germany
 
112-7516071-6/2/1 17-May-2012 62SIZ03 3009539257 Xingcheng Chempharm Co Ltd China
 
AEK-0300751-1/1/1 09-May-2012 62VCA48 3001751909 Ajanta Pharma Limited India
 
066-0225010-9/1/1 02-May-2012 62VCS99 3002808087 Schering-Plough (Brinny) Co. Ireland
 
066-0225010-9/2/1 02-May-2012 62VCS99 3002808087 Schering-Plough (Brinny) Co. Ireland
 
112-7954025-0/1/1 21-May-2012 62VDA42 3003699941 Cipla Ltd India
 
112-7209244-1/1/1 23-May-2012 62VIA99 2529019 Fisher Clinical Services, Inc. United States
 
112-7209244-1/1/2 23-May-2012 62VIA99 2529019 Fisher Clinical Services, Inc. United States
 
112-7209244-1/1/3 23-May-2012 62VIE99 2529019 Fisher Clinical Services, Inc. United States
 
112-7209244-1/1/4 23-May-2012 62VIE99 2529019 Fisher Clinical Services, Inc. United States
 
MA7-0112512-6/1/1 17-May-2012 62WAL17 3004101321 Shieling Laboratories Ltd New Zealand
 
H87-0196568-8/1/1 25-May-2012 62WBL17 2000010864 Cosbel S.A. de C.V. Mexico
 
H87-0196568-8/1/2 25-May-2012 62WBL17 2000010864 Cosbel S.A. de C.V. Mexico
 
H87-0196568-8/1/3 25-May-2012 62WBL17 2000010864 Cosbel S.A. de C.V. Mexico
 
H87-0196568-8/1/4 25-May-2012 62WBL17 2000010864 Cosbel S.A. de C.V. Mexico
 
H87-0196568-8/1/5 25-May-2012 62WBL17 2000010864 Cosbel S.A. de C.V. Mexico
 
H87-0196568-8/1/6 25-May-2012 62WBL17 2000010864 Cosbel S.A. de C.V. Mexico
 
H87-0196568-8/1/7 25-May-2012 62WBL17 2000010864 Cosbel S.A. de C.V. Mexico
 
H87-0196568-8/1/8 25-May-2012 62WBL17 2000010864 Cosbel S.A. de C.V. Mexico
 
H87-0196568-8/1/9 25-May-2012 62WBL17 2000010864 Cosbel S.A. de C.V. Mexico
 
UPS-5981963-7/2/1 03-May-2012 62WBR99 3008946123 Bracey Pharma United Kingdom
 
112-7089706-4/1/1 04-May-2012 62WCT11 3003887583 Farma Quimia S.A. de C.V. Mexico
 
UPS-6018047-4/1/1 03-May-2012 62ZCY10 3005753354 Sanofi Aventis United Kingdom
 
UPS-5994621-6/1/1 08-May-2012 62ZCY10 3009488444 R X Source C/O.Airline Int'L United Kingdom
 
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