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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 62-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
WRE-0356119-8/1/1 26-Mar-2008 62CAY41 1000602688 Jiangyin Jinjang Garment Mill China
 
112-1777626-2/1/1 18-Mar-2008 62CCP99 3006533143 Amoum Co Egypt
 
112-1777626-2/1/3 18-Mar-2008 62CCP99 3006717606 Glaxo Co Egypt
 
112-1777626-2/1/2 18-Mar-2008 62CCP99 3006717609 Waith Co Egypt
 
AEK-7960418-3/2/1 19-Mar-2008 62CDY65 3006483459 Oconnell John Canada
 
DQ4-3609691-0/1/1/A 19-Mar-2008 62FBL47 3006461016 Sourcology Ltd Hong Kong SAR
 
DQ4-3609691-0/1/1/B 19-Mar-2008 62FBL47 3006461016 Sourcology Ltd Hong Kong SAR
 
UPS-0013721-4/1/5 06-Mar-2008 62GCA18 3006301931 Bruluart S.A. Mexico
 
UPS-0165435-7/1/1/E 13-Mar-2008 62GCC48 3006685116 Unaiza Rana Canada
 
231-7035507-0/1/1 17-Mar-2008 62GCS99 3002808116 Piramal Healthcare UK Limited United Kingdom
 
231-7035507-0/3/1 17-Mar-2008 62GCS99 3002808116 Piramal Healthcare UK Limited United Kingdom
 
231-7035507-0/2/1 17-Mar-2008 62GCS99 3002808116 Piramal Healthcare UK Limited United Kingdom
 
XXX-0153631-8/1/4 14-Mar-2008 62GDA18 3001056209 unknown India
 
XXX-0153631-8/1/5 14-Mar-2008 62GDA18 3001056209 unknown India
 
XXX-0151441-4/1/8 13-Mar-2008 62GDB18 2000015772 Farmacaps, S.A. Guatemala
 
112-1777986-0/1/1 28-Mar-2008 62GIA50 3005032659 Roche Canada Canada
 
112-1711046-2/1/1 12-Mar-2008 62GIY41 3003066407 Shasun Chemicals And Drugs Ltd. India
 
D21-0047080-8/5/1 25-Mar-2008 62HAJ99 3005798739 Ningbo Well May Imp. & Exp. Co. Ltd China
 
112-1657959-2/1/1 12-Mar-2008 62ICA72 3005464934 Roche Pharma Switzerland
 
112-1657959-2/1/2 12-Mar-2008 62ICA72 3005464934 Roche Pharma Switzerland
 
UPS-0165435-7/1/1/B 13-Mar-2008 62KCC10 3006685116 Unaiza Rana Canada
 
XXX-0153758-9/3/1 24-Mar-2008 62KDA08 3001362755 Unknown Peru
 
AEK-7749384-5/2/12 28-Mar-2008 62LCB40 3002106632 Global Rx Inc United States
 
112-1926358-2/1/1 28-Mar-2008 62LCJ50 3003671557 G Production Inc Canada
 
AEK-6745182-9/1/1 01-Mar-2008 62LJL51 3006668066 Genop Healthcare United Kingdom
 
D52-8900831-5/45/1 19-Mar-2008 62MBJ08 3006639240 Be-Tabs Pharmaceuticals (Pty) LTD South Africa
 
112-8875215-9/2/1 12-Mar-2008 62OCB12 3006528150 Apotek Greaker Norway
 
112-0138411-5/1/2 06-Mar-2008 62OCB24 3005696785 Sanofi Synthelado Venezuela
 
112-0138411-5/1/1 06-Mar-2008 62OCB37 3005106102 Lab Pharma Venezuela Venezuela
 
AEK-7749384-5/2/1 28-Mar-2008 62OCB48 3002106632 Global Rx Inc United States
 
UPS-0165435-7/1/1/C 13-Mar-2008 62OCC44 3006685116 Unaiza Rana Canada
 
112-0099448-4/1/1 06-Mar-2008 62TCB06 3006541635 Astra Zeneca United States
 
UPS-0030157-0/1/1 05-Mar-2008 62UCA01 3005557868 Todo Pak S De Rl De Cv Mexico
 
UPS-0146857-6/1/1 13-Mar-2008 62UIM01 3001743983 Novartis Farmaceutica S.A. De C.V. Mexico
 
AEK-7749384-5/2/10 28-Mar-2008 62VCB18 3002106632 Global Rx Inc United States
 
112-1463390-4/1/1 25-Mar-2008 62VCS99 3002807864 Novasep Freeport (Pharmachem Technologies) Bahamas
 
112-1445512-6/1/1 06-Mar-2008 62VIY23 3000126720 Hetero Drugs Limited India
 
UPS-0013721-4/1/8 06-Mar-2008 62YCA07 3006620576 Pakmail Cholula Mexico
 
112-8883957-6/1/1 12-Mar-2008 62ZCA10 3003195501 Sanofi-Aventis Deutschland GmbH Germany
 
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