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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
112-2788751-5/4/1 16-Aug-2011 63BCS02 3002806958 FDC, Ltd. India
 
UPS-2879033-1/1/1 01-Aug-2011 63BDZ25 3006688119 Citinetwork India
 
UPS-3191424-1/1/1 24-Aug-2011 63ECY13 3006776843 Pakmail San Luis Potosi Mexico
 
112-0606497-9/1/1 23-Aug-2011 63EIS18 3006575404 Shanghai Hanhong Chemical Co., Ltd. China
 
112-2968727-7/1/1 23-Aug-2011 63FCP15 3002647489 Gland Pharma Limited India
 
112-1718704-1/3/1 24-Aug-2011 63HAA22 3002807985 Reckitt Benckiser Healthcare (U.K.) Limited United Kingdom
 
940-0175111-7/1/17 10-Aug-2011 63HAL08 3004207724 Farm Invest Ukraine
 
112-2552701-4/1/1 16-Aug-2011 63HBZ06 3008952079 Farmalabor Italy
 
XXX-0175864-0/1/1 22-Aug-2011 63HCR25 3009032463 Cathy Maydaniuk Canada
 
112-0438218-3/1/1 24-Aug-2011 63NCP06 3004860873 Methapharm Inc Canada
 
112-2176531-1/1/1 12-Aug-2011 63NIL22 3004413313 Vegeflora Extracoes Do Nordeste Ltda Brazil
 
112-3303578-6/8/1 29-Aug-2011 63RBJ06 3004860449 Colgate Palmolive Germany
 
112-3303578-6/8/2 29-Aug-2011 63RBJ06 3004860449 Colgate Palmolive Germany
 
112-3303578-6/8/3 29-Aug-2011 63RBJ06 3004860449 Colgate Palmolive Germany
 
112-3303578-6/8/5 29-Aug-2011 63RBJ06 3006118127 Gaba Gmbh Germany
 
112-3407552-6/1/1 29-Aug-2011 63RBJ06 3006118127 Gaba Gmbh Germany
 
BLO-1208997-1/1/1 11-Aug-2011 63RBY06 3008993923 Boryeong Health & Life Co., Ltd Korea, Republic Of (South)
 
H77-0127560-1/10/1 16-Aug-2011 63RKJ06 3008468427 Wf Limited India
 
AEK-8797088-1/1/1 01-Aug-2011 63XCY99 3009007343 Centurion Formulation India
 
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