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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 63-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-6891599-2/1/2 12-Jan-2012 63BCO25 3004459813 Glaxosmithkline Brazil
 
112-9653586-0/1/1 12-Jan-2012 63BCQ99 3004603791 GlaxoSmithKline Spain
 
BER-4066326-0/1/1 18-Jan-2012 63BCS30 3002807400 BASF PharmaChemikalien Gmbh & Co. KG Germany
 
101-9636431-8/1/1 23-Jan-2012 63BDR25 3009234123 Vectura Ltd United Kingdom
 
112-9717772-0/1/1 07-Jan-2012 63NAB23 3003462429 Biznet C.A. Venezuela
 
XXX-0176546-1/2/24 24-Jan-2012 63NDO03 3009203229 henie laboratories Honduras
 
KM6-0054829-1/3/1 11-Jan-2012 63RAY99 3009222637 Keval Exports Pvt Limited India
 
D52-0596099-5/9/1/B 26-Jan-2012 63RB03 3009328552 GABA international Poland
 
D52-0596099-5/9/1/C 26-Jan-2012 63RB03 3009328552 GABA international Poland
 
D52-0596099-5/9/1/A 26-Jan-2012 63RB06 3009328552 GABA international Poland
 
D52-0596099-5/9/1/E 26-Jan-2012 63RBL03 3009328552 GABA international Poland
 
D52-0596099-5/9/1/D 26-Jan-2012 63RBL04 3009328552 GABA international Poland
 
112-4436959-6/1/1 19-Jan-2012 63RBL05 2000024870 Amar Remedies Ltd. India
 
D52-0596099-5/9/1/G 26-Jan-2012 63RBY04 3008225929 Ilirija D.D. Slovenia
 
D52-0596099-5/9/1/F 26-Jan-2012 63RBY06 3009328552 GABA international Poland
 
F57-6114245-7/4/1 31-Jan-2012 63RKA04 3004737602 Willard Manufacturing Inc. Canada
 
F57-6114245-7/2/1 31-Jan-2012 63RKA04 3004737602 Willard Manufacturing Inc. Canada
 
F57-6114245-7/3/1 31-Jan-2012 63RKA04 3004737602 Willard Manufacturing Inc. Canada
 
112-7443802-1/2/1 07-Jan-2012 63VBL99 3008353190 Euoko Inc Canada
 
M76-1606170-3/11/1 20-Jan-2012 63VCJ02 3002808384 Taro Pharmaceuticals, Inc. Canada
 
112-5639034-9/1/1 07-Jan-2012 63VIS02 3004889340 Valeant Canada Ltd. Canada
 
EJG-0225833-9/10/1/E 04-Jan-2012 63WAL99 3009043409 Nisa Today Ltd United Kingdom
 
EJG-0225833-9/10/1/F 04-Jan-2012 63WAY99 3009043409 Nisa Today Ltd United Kingdom
 
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