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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 65-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
112-4012299-9/2/1 26-Sep-2011 65BQZ99 3005609113 Lyppard Australia Limited Australia
 
112-4012299-9/2/2 26-Sep-2011 65CRN03 3005609113 Lyppard Australia Limited Australia
 
315-8159008-5/18/1 09-Sep-2011 65DDP06 3006362085 Alliance Pharmaceuticals Ltd United Kingdom
 
MA7-0578075-1/1/1 20-Sep-2011 65FA06 3005320466 Opto-Pharm Pte Ltd. Singapore
 
MA7-0578075-1/1/2 20-Sep-2011 65FA06 3005320466 Opto-Pharm Pte Ltd. Singapore
 
MA7-0578075-1/1/3 20-Sep-2011 65FA06 3005320466 Opto-Pharm Pte Ltd. Singapore
 
MA7-0578075-1/1/4 20-Sep-2011 65FA06 3005320466 Opto-Pharm Pte Ltd. Singapore
 
112-2991873-0/1/1 13-Sep-2011 65FBL99 3003333306 Laboradaze Pasquier France
 
AR8-2008781-5/1/1 07-Sep-2011 65FCL99 3008469944 Antai Bio-Tech Co China
 
277-0130405-0/7/1 23-Sep-2011 65GBU99 3008419342 Takka Inter Service Co., Ltd. Thailand
 
277-0130405-0/8/1 23-Sep-2011 65GBU99 3008419342 Takka Inter Service Co., Ltd. Thailand
 
277-0130405-0/10/1 23-Sep-2011 65GBU99 3008419342 Takka Inter Service Co., Ltd. Thailand
 
277-0130405-0/13/1 23-Sep-2011 65GBU99 3008419342 Takka Inter Service Co., Ltd. Thailand
 
277-0130405-0/16/1 23-Sep-2011 65GBU99 3008419342 Takka Inter Service Co., Ltd. Thailand
 
277-0130405-0/17/1 23-Sep-2011 65GBU99 3008419342 Takka Inter Service Co., Ltd. Thailand
 
277-0130405-0/18/1 23-Sep-2011 65GBU99 3008419342 Takka Inter Service Co., Ltd. Thailand
 
277-0130405-0/20/1 23-Sep-2011 65GBU99 3008419342 Takka Inter Service Co., Ltd. Thailand
 
277-0130405-0/21/1 23-Sep-2011 65GBU99 3008419342 Takka Inter Service Co., Ltd. Thailand
 
277-0130405-0/25/1 23-Sep-2011 65GBU99 3008419342 Takka Inter Service Co., Ltd. Thailand
 
ANJ-0011143-2/2/1 19-Sep-2011 65GCY99 3007880724 Jiangyin Eusuntex China
 
112-3706087-1/1/1 16-Sep-2011 65JAP16 3006635337 October Pharma Egypt
 
112-9138074-3/1/1 09-Sep-2011 65JCA31 3008021142 Lab Procaps Sa Colombia
 
UPS-3313361-8/1/5 09-Sep-2011 65JCK31 3009076332 Juana Hernandez Alonzo Guatemala
 
315-8159008-5/16/1 09-Sep-2011 65KCA09 3002807868 Pfizer, Ltd. United Kingdom
 
112-9090203-4/1/1 09-Sep-2011 65PCA02 3008546425 Centurion Laboratories India
 
AEK-8382354-8/3/5 22-Sep-2011 65PCL99 3008036717 Paracelsus Klinik Switzerland
 
UPS-3422405-1/1/2 14-Sep-2011 65PCY03 3006357412 Zydus Pharmaceuticals United States
 
112-2968727-7/2/1 06-Sep-2011 65RCP20 3002647489 Gland Pharma Limited India
 
112-2968727-7/2/2 06-Sep-2011 65RCP20 3002647489 Gland Pharma Limited India
 
112-9042680-2/1/1 09-Sep-2011 65VCA56 3003219179 Sanofi Sante Labo Switzerland
 
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