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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal W69-3206414-1/11/1/C


Manufacturer FEI3008202820
Manufacturer NameReckitt Benckiser Pakistan Ltd  
Manufacturer Address line 1Gpo Box No 625  
Manufacturer Address line 2  
Manufacturer's CityKarachi  
Manufacturer Province/State  
Manufacturer Country/AreaPakistan  
Product Code53JK01  
Importer's Product DescriptionMOUTH FRESHENER  
Refusal Date01-Nov-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx W69-3206414-1/11/1/C
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
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