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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
KM6-0023010-6/1/1 11-Aug-2005 62FCJ08 1000231335 Tsang Fook Kee Medicine Co. Hong Kong SAR
 
KM6-0023010-6/1/2 11-Aug-2005 62FCJ08 1000231335 Tsang Fook Kee Medicine Co. Hong Kong SAR
 
XXX-0110893-6/1/48 05-Aug-2005 62GAR99 3004581869 La boratorios Unido S.A. Guatemala
 
AEK-7053111-2/1/1 17-Aug-2005 62GAR99 1000133185 Amsar Private Ltd India
 
AEK-7052051-1/3/1 17-Aug-2005 62GAY99 3005207906 Zimbabwe Traditional Healers Association Zimbabwe
 
M21-0731403-3/1/1 24-Aug-2005 62GBA41 3004850451 Wendt-Chemie Vertriebsges Mbh & Co. Germany
 
XXX-0110893-6/1/40 05-Aug-2005 62GCA18 3003339540 Unipharm S.A Guatemala
 
XXX-0110893-6/1/1 05-Aug-2005 62GCA41 1000281220 Corporacion Bonimas Sa El Salvador
 
XXX-0110893-6/1/19 05-Aug-2005 62GCH42 3003983354 Merck Sharp & Dohme (I.A.) Corp. Costa Rica
 
XXX-0110893-6/1/7 05-Aug-2005 62GDA90 3004121489 Laboratorios Donavan Werke AGSA Int'l Guatemala
 
310-9694036-1/1/1 22-Aug-2005 62GDB99 3003925243 Quinte Pharmacy Canada
 
112-7856407-5/2/1 19-Aug-2005 62GDK99 3002808072 Santen Pharm. Co., Ltd. Japan
 
SG5-0409146-6/1/1 31-Aug-2005 62GIZ99 3000264888 Patheon Inc. - Toronto Region Operations Canada
 
110-1319933-0/1/1 03-Aug-2005 62IIY93 3004150902 Liaoning Huaning International Corp. China
 
XXX-0123585-3/1/5 18-Aug-2005 62JCA13 3005135374 Wyeth-Whitehall S.A. France
 
112-7909039-3/1/1 30-Aug-2005 62JCP14 3003693042 Kurier & Logistik Service Ohg Germany
 
AEK-7049677-9/1/8 15-Aug-2005 62KCA10 3005187156 Rashid Abdulaziz Al Duaij Saudi Arabia
 
AEK-7052596-5/1/2 17-Aug-2005 62LCA30 3005179732 Materno Infantil Dominican Republic
 
AEK-7053977-6/2/4 12-Aug-2005 62LOA01 3000939205 Apotheek Jorissen Nv Belgium
 
W69-1229994-9/1/1 04-Aug-2005 62MAY08 3004946373 Shanghai Wanxiang Flavors China
 
144-5423329-9/1/1 01-Aug-2005 62MBQ01 3005086577 Jss International Link Ltd Canada
 
AEK-7049677-9/1/2 15-Aug-2005 62OCA14 3005187156 Rashid Abdulaziz Al Duaij Saudi Arabia
 
XXX-0123585-3/1/6 18-Aug-2005 62OCA19 3005258776 Astra Zeneca S.A. Argentina
 
XXX-0110893-6/1/35 05-Aug-2005 62OCA28 1000281220 Corporacion Bonimas Sa El Salvador
 
AEK-7049677-9/1/5 15-Aug-2005 62OCA41 3005187156 Rashid Abdulaziz Al Duaij Saudi Arabia
 
AEK-6673129-6/1/1 08-Aug-2005 62ODA03 3005213917 Mapette Dimacali Philippines
 
BNW-0512454-1/1/1/B 19-Aug-2005 62SBL03 1000424648 Sesderma Spain
 
AEK-7052596-5/1/1 17-Aug-2005 62TCA06 3005212098 Debbie Braddon South Africa
 
506-0812609-5/1/1 03-Aug-2005 62TCA99 2410924 Pfizer, Inc. United States
 
AEK-7052386-1/1/1 17-Aug-2005 62UAA99 3005210755 T.V. Holay India
 
AEK-7052386-1/1/2 17-Aug-2005 62UAA99 3005210755 T.V. Holay India
 
AEK-7052386-1/1/3 17-Aug-2005 62UAA99 3005210755 T.V. Holay India
 
AEK-7052386-1/1/4 17-Aug-2005 62UAA99 3005210755 T.V. Holay India
 
XXX-0110893-6/1/13 05-Aug-2005 62UBK11 3003339540 Unipharm S.A Guatemala
 
XXX-0110893-6/1/26 05-Aug-2005 62UDK11 3004161285 Laboratorios Farkot, S.A. Guatemala
 
112-8236011-4/2/1 31-Aug-2005 62VAL99 3005192251 Kindin Medical Research Institut China
 
D52-0910704-9/1/3 03-Aug-2005 62VBL99 3003955782 Apex Well (Asia) Limited Hong Kong SAR
 
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