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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
XXX-0175227-9/3/2 20-May-2011 56BCA03 3001027464 UNKNOWN Guatemala
 
XXX-0175214-7/2/2 17-May-2011 56BCE03 3004881451 Okasa Pvt. Ltd. India
 
XXX-0175213-9/2/2 17-May-2011 56BCE05 3003489017 Antibiotice S.A. Romania
 
XXX-0174905-1/1/1 17-May-2011 56BDR03 1035048 GlaxoSmithKline United States
 
XXX-0173987-0/1/2 17-May-2011 56BDY03 3000983371 Unknown El Salvador
 
XXX-0173987-0/1/3 17-May-2011 56BDY05 3000983371 Unknown El Salvador
 
XXX-0175227-9/3/5 20-May-2011 56CDP70 3001027464 UNKNOWN Guatemala
 
XXX-0175214-7/2/1 17-May-2011 56ECE81 3004881451 Okasa Pvt. Ltd. India
 
XXX-0175227-9/3/1 20-May-2011 56ECE99 3001027464 UNKNOWN Guatemala
 
XXX-0269136-9/1/4 04-May-2011 56ECY81 3006182617 Microlabs Limited India
 
XXX-0268571-8/1/1 17-May-2011 56ECY81 3005354027 Mk Pharmaceutical El Salvador
 
XXX-0268573-4/1/1 17-May-2011 56ECY81 3005354027 Mk Pharmaceutical El Salvador
 
XXX-0268520-5/1/8 17-May-2011 56ECY81 3004740219 Laboratorios Therfam Guatemala
 
112-0643033-7/1/1 17-May-2011 56JCS22 3003758123 Zhejiang Hisor Pharm & Chem Co Ltd China
 
XXX-0175213-9/2/3 17-May-2011 56KDA99 3006253465 Zentiva S.A. Romania
 
XXX-0175222-0/3/1 17-May-2011 56KDA99 3000983371 Unknown El Salvador
 
XXX-0269819-0/1/3 12-May-2011 56YAY99 3007208956 Okasa Pharma Pvt Ltd India India
 
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