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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 56-Antibiotics (Human/Animal)


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
N90-1049305-0/6/1 12-Jan-2012 56BAH03 3003941090 Medopharm Mohan Mansions India
 
N90-1049305-0/4/1 12-Jan-2012 56BAR03 3006133981 Alkem House India
 
112-9196840-6/1/1 06-Jan-2012 56BCK52 1000208638 King Legacy, a wholly owned subsidiary of Pfizer United States
 
XXX-0176546-1/2/34 24-Jan-2012 56DDO41 3003916517 Unipharma International, SA Guatemala
 
N90-1049305-0/10/1 12-Jan-2012 56ECC22 3006037082 Nanjing Baijingyu Pharmaceutical Co Ltd China
 
XXX-0176546-1/2/5 24-Jan-2012 56EDB20 3001617666 Apotex Inc Canada
 
N90-1049305-0/16/1 12-Jan-2012 56FBJ13 3006585374 Galentic Pharma Pvt Ltd India
 
112-8987420-2/1/1 06-Jan-2012 56FDS30 3003995556 Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd China
 
XXX-0176546-1/2/14 24-Jan-2012 56JDJ20 3004259935 Laboratorios ANDIFAR Honduras
 
M21-0745060-5/2/1 23-Jan-2012 56YYK99 3004850451 Wendt-Chemie Vertriebsges Mbh & Co. Germany
 
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