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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
112-4083345-4/3/1 17-Oct-2011 62CDA65 3003495098 Astrazeneca United States
 
112-8897718-7/1/1 28-Oct-2011 62CIY51 3006258640 Alcon Biosciences Pvt Ltd India
 
112-9749690-6/1/1 27-Oct-2011 62FAO99 3005458209 Rye Pharmaceuticals Australia
 
112-4412146-8/3/1 19-Oct-2011 62FAY23 3008589557 Fab Medical Limited United Kingdom
 
112-3546401-8/1/1 07-Oct-2011 62FBJ99 3009070392 Propharmatech Ltd Hungary
 
112-3546401-8/1/2 07-Oct-2011 62FBJ99 3009070392 Propharmatech Ltd Hungary
 
BRQ-0087922-2/2/1 19-Oct-2011 62GAL99 3004397191 TECNO BOTANICA DE MEXICO SA DE CV Mexico
 
EG6-2241846-5/1/1 27-Oct-2011 62GAL99 3004691717 Mikhail Zayat Enr Canada
 
112-9030626-9/2/1 05-Oct-2011 62GBO18 3002616705 Novartis Consumer Health Canada, Inc. Canada
 
AEK-8489367-2/1/1 12-Oct-2011 62GBY99 3004077415 Ebos Group New Zealand
 
EU7-2111093-7/2/5 24-Oct-2011 62GBY99 3003564117 M/S. Suprabharath Exports Pvt. Ltd. India
 
112-8269394-8/2/1 03-Oct-2011 62GCA18 3004962120 Casasco Argentina
 
M21-0744388-1/2/1 04-Oct-2011 62GCB94 3007522260 Lyka Bdr International Ltd India
 
112-4097563-6/2/1 12-Oct-2011 62GCL99 1610287 Alcon Research, Ltd. United States
 
112-4122465-3/1/1 18-Oct-2011 62GCY18 3006608553 Norvartis Corp Italy
 
112-4122401-8/1/1 18-Oct-2011 62GCY18 3006608553 Norvartis Corp Italy
 
UPS-3556170-9/2/2 06-Oct-2011 62GCY90 3006475565 Genfar Colombia
 
186-3847047-8/3/1 14-Oct-2011 62HBL99 3010219104 Micrylium Laboratories Canada
 
112-8537872-9/1/1 03-Oct-2011 62IQB99 3003563645 Catalent Pharma Solutions, LLC United States
 
112-8537872-9/1/2 03-Oct-2011 62IQB99 3003563645 Catalent Pharma Solutions, LLC United States
 
112-4012178-5/1/1 24-Oct-2011 62JCZ09 3005588412 DU-HOPE INTERNATIONAL GROUP China
 
112-8457846-9/2/1 03-Oct-2011 62KAA10 3004512630 Grupo Roche Syntex De Mixixo Sa Mexico
 
112-9605693-3/1/1 28-Oct-2011 62KAA10 3007675973 Alembic Ltd India
 
112-4082741-5/1/2 24-Oct-2011 62OCB03 3008811365 Servtechindustrial Component Services Ireland
 
112-9881294-5/1/1 27-Oct-2011 62OCB14 3007972194 Windlass Steelcrafts India
 
112-4002152-2/5/1 12-Oct-2011 62OCC22 3002807936 Productos Roche Quimicos E Farmaceuticos Brazil
 
112-4002152-2/1/1 12-Oct-2011 62OCC41 3002806642 Dr. Reddy's Laboratories India
 
112-8269394-8/1/1 03-Oct-2011 62OCE14 3006487625 Pfizer Sa Ppg La Plaine Belgium
 
112-9881294-5/1/3 27-Oct-2011 62ODA05 3005890633 Intas Pharmaceuticals India
 
112-4083345-4/4/1 17-Oct-2011 62ODA32 2518137 AstraZeneca Pharmaceuticals LP United States
 
112-5441075-9/2/1 27-Oct-2011 62ODC05 3004627510 Aventis Pharma Ltd India
 
XXX-0276327-5/1/3 17-Oct-2011 62ODY19 3005165299 Astrazeneca Sverige Ab Sweden
 
UPS-3734202-5/2/1/B 03-Oct-2011 62SBL99 3003420009 CMI Cosmetic Manufacturers Inc. Canada
 
112-5441075-9/1/1 27-Oct-2011 62TDC02 3004447666 Takeda Global Research & Development United States
 
112-9766280-4/1/1 28-Oct-2011 62UDA08 3007952973 Ssl International United Kingdom
 
112-9259489-5/1/1 28-Oct-2011 62VCK31 3000283924 Abbot Laboratorios De Colombia S.A. Colombia
 
112-4122465-3/1/2 18-Oct-2011 62VCS99 3008022197 Mylan Spa Italy
 
112-4122401-8/1/2 18-Oct-2011 62VCS99 3008022197 Mylan Spa Italy
 
EGG-0007416-4/1/1 11-Oct-2011 62WBL99 3003483565 Hbc Inc Philippines
 
EGG-0007416-4/5/1/A 11-Oct-2011 62WBL99 3003483565 Hbc Inc Philippines
 
EGG-0007416-4/5/1/C 11-Oct-2011 62WBL99 3003483565 Hbc Inc Philippines
 
EGG-0007416-4/20/1 11-Oct-2011 62WBL99 3003483565 Hbc Inc Philippines
 
ARE-4125887-7/2/1/B 05-Oct-2011 62WBQ99 3008394391 A Unilever Brand United Kingdom
 
EGG-0007416-4/18/1 11-Oct-2011 62WBY99 3003483565 Hbc Inc Philippines
 
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