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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
224-0360975-7/1/2 04-Aug-2008 60CCP04 3005339463 Hospira, Inc. United States
 
224-0360975-7/1/10 04-Aug-2008 60CCP04 3005339463 Hospira, Inc. United States
 
112-1640058-3/2/1/A 21-Aug-2008 60LAP99 3003305289 The Boots Company Plc United Kingdom
 
112-1640058-3/2/1/C 21-Aug-2008 60LAP99 3003305289 The Boots Company Plc United Kingdom
 
112-1640058-3/2/1/B 21-Aug-2008 60LAP99 3003305289 The Boots Company Plc United Kingdom
 
BQL-0016816-9/5/1 05-Aug-2008 60LAY07 3004434112 Galafarm Ukraine
 
HD8-0089119-8/1/1/E 05-Aug-2008 60LBJ07 3006742009 PZ Nigeria Limited Nigeria
 
411-8164487-7/17/1 18-Aug-2008 60LBJ99 3006744199 Makson Industries Pvt. Ltd. India
 
411-8164487-7/14/1 18-Aug-2008 60LBL99 3006480587 Emami Limited India
 
FS2-8010611-3/4/5 14-Aug-2008 60LBO04 3004313288 Xiamen Traditional Chinese Medicine Co., Ltd. China
 
112-1503714-7/1/1 22-Aug-2008 60LCA86 3003513196 Laboratoire Glaxosmithkline France
 
EI5-5118464-7/1/1 04-Aug-2008 60LCK99 2026154 Amgen, Inc. United States
 
224-0360975-7/1/5 04-Aug-2008 60LCP01 1420763 Medique Products United States
 
UPS-1704055-9/1/8 04-Aug-2008 60LLK71 3005853497 Phoenix Scientific United States
 
UPS-1704055-9/1/3 04-Aug-2008 60NCY14 3004001493 Todo Pak Mexico
 
224-0360975-7/1/11 04-Aug-2008 60QCP07 3005339463 Hospira, Inc. United States
 
BGK-0025378-2/7/1 11-Aug-2008 60SAR99 3004512975 Southern Drugs & Pharmaceuticals India
 
AEK-9683878-0/1/1 29-Aug-2008 60SBY99 3006770417 World Health Products South Africa
 
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