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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 60-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-2441278-8/1/66 11-Sep-2012 60CCA57 1818658 The Harvard Drug Group, LLC United States
 
112-2441278-8/1/13 11-Sep-2012 60CCA57 1922351 KV Pharmaceutical Co United States
 
112-2441278-8/1/61 11-Sep-2012 60CCK04 3005579246 Hospira Inc. United States
 
112-2441278-8/1/55 11-Sep-2012 60CCK04 3005579246 Hospira Inc. United States
 
112-2441278-8/1/20 11-Sep-2012 60CCK04 3005579246 Hospira Inc. United States
 
KH5-0066931-3/1/1 20-Sep-2012 60CCS09 3002806556 Boehringer Ingelheim Pharma GmbH & Co. KG Germany
 
KH5-0066305-0/1/1 20-Sep-2012 60CCS09 3002806556 Boehringer Ingelheim Pharma GmbH & Co. KG Germany
 
112-2441278-8/1/12 11-Sep-2012 60CCY04 3008751485 Dey Pharma United States
 
523-0973318-7/1/1 26-Sep-2012 60ECT01 3007516248 Shanghai Record Ph China
 
AEK-0312386-2/4/1 21-Sep-2012 60HCA99 3009711055 Care Hospital India
 
112-2441278-8/1/67 11-Sep-2012 60JCK02 3003433073 Pharmatek United States
 
9ED-0001258-9/2/1 27-Sep-2012 60LAS01 3008068667 Quimica Y Farmacia Sa De Cv Mexico
 
112-9092937-6/1/1/A 18-Sep-2012 60LBL99 3003929522 Noelville Ltd. Grenada
 
112-9092937-6/1/1/B 18-Sep-2012 60LBL99 3003929522 Noelville Ltd. Grenada
 
112-9092937-6/1/1/C 18-Sep-2012 60LBL99 3003929522 Noelville Ltd. Grenada
 
112-2441278-8/1/43 11-Sep-2012 60LCA01 3006461997 Akyma Pharmaceuticals United States
 
112-8730371-8/1/1 07-Sep-2012 60LCL99 3008855266 Shree Marwal Sevashram India
 
UPS-7759968-2/1/1 24-Sep-2012 60QBY67 3009556682 Shin Sachi Pharmaceutical Canada
 
112-2441278-8/1/42 11-Sep-2012 60QCK07 3006441852 Abraxis Bioscience LLC United States
 
112-2441278-8/1/48 11-Sep-2012 60QCO34 2450054 Perrigo New York United States
 
XXX-0224450-8/1/7 18-Sep-2012 60QDY46 3005291965 Lab. Arbofarma Sa. Colombia
 
112-8729815-7/1/1 14-Sep-2012 60RDE18 3005895033 Laborado Chiles Chile
 
112-8729815-7/1/2 14-Sep-2012 60RDE18 3005895033 Laborado Chiles Chile
 
KM6-0057227-5/17/1 21-Sep-2012 60SBZ99 3004512975 Southern Drugs & Pharmaceuticals India
 
112-2441278-8/1/30 11-Sep-2012 60SCA04 1419642 Rugby Laboratories, Inc. United States
 
112-2441278-8/1/23 11-Sep-2012 60SCA06 3002047518 IVAX Pharmaceuticals United States
 
112-9321230-9/1/1 28-Sep-2012 60SDH27 3008204842 Torren Pharmaceuticals India
 
112-2441278-8/1/37 11-Sep-2012 60WCA16 3003092769 Teva Pharmaceuticals USA United States
 
112-9266494-8/1/1 17-Sep-2012 60WCT12 3008201680 Pancea Biotec India
 
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