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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
AEK-0312386-2/5/2 21-Sep-2012 63ACB99 3009711055 Care Hospital India
 
112-2441278-8/1/31 11-Sep-2012 63BCQ27 1222021 Sunovion Pharmaceuticals Inc. United States
 
112-6669240-4/1/1 14-Sep-2012 63DCA01 3002808385 Taro Pharmaceutical Industries, Ltd. Israel
 
112-2441278-8/1/16 11-Sep-2012 63ECK18 3002160581 Fujisawa Health Care Inc United States
 
112-2441278-8/1/19 11-Sep-2012 63FCK04 3007379904 Glasko Wellcome United States
 
112-2441278-8/1/26 11-Sep-2012 63ICK01 2127022 Paddock Laboratories, LLC United States
 
371-3151441-8/1/1 18-Sep-2012 63NAS09 3000983580 Pro Spa Italy
 
F23-9070672-9/5/3 20-Sep-2012 63RAY99 3008978601 Concorde Marketing Pte Ltd Singapore
 
F23-9070672-9/5/1 20-Sep-2012 63RAY99 3008978601 Concorde Marketing Pte Ltd Singapore
 
F23-9070672-9/5/2 20-Sep-2012 63RAY99 3008978601 Concorde Marketing Pte Ltd Singapore
 
KM6-0058659-8/10/1 18-Sep-2012 63RBJ06 3009566734 Sudhir Sheth India
 
H77-0131840-1/7/1 05-Sep-2012 63RBY06 3009037574 Colgate Palmolive India Ltd India
 
H77-0131840-1/12/1 05-Sep-2012 63RBY06 3006523241 Hindustan Unilever Limited India
 
H77-0131840-1/12/2 05-Sep-2012 63RBY06 3009037574 Colgate Palmolive India Ltd India
 
KM6-0057782-9/2/1 21-Sep-2012 63RBY06 3008468427 Wf Limited India
 
MH7-7002362-9/19/3 25-Sep-2012 63RDY05 3009688282 Kgl Services Express Ivory Coast
 
MH7-7002362-9/19/4 25-Sep-2012 63RDY05 3009688282 Kgl Services Express Ivory Coast
 
AEK-0285429-3/1/2 07-Sep-2012 63VAO02 3004635339 Laboratorios Portugal Peru
 
ED5-0046189-9/5/1/C 14-Sep-2012 63VBJ02 3008325077 Angel Cosmetics Congo, Dem Rep of (Kinshasa)
 
UPS-4486013-2/30/1 14-Sep-2012 63VBL99 3000999767 Entreprises Importfab Inc. Canada
 
UPS-4486013-2/3/1 14-Sep-2012 63VCJ02 3000999767 Entreprises Importfab Inc. Canada
 
UPS-4486013-2/23/1 14-Sep-2012 63VCJ02 3000999767 Entreprises Importfab Inc. Canada
 
112-2441278-8/1/28 11-Sep-2012 63WCK07 3002960808 PURDUE Pharmaceuticals Lp United States
 
112-8828790-2/1/1 14-Sep-2012 63XCP12 3006217304 Contacare Ophthalmics & Diagnostics India
 
112-8828790-2/2/3 14-Sep-2012 63XDK99 3006217304 Contacare Ophthalmics & Diagnostics India
 
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