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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 AGT-0005049-3/7/1

Manufacturer FEI3003887465
Manufacturer NameDarksha Trading  
Manufacturer Address line 1P.O.Box 11963  
Manufacturer Address line 2  
Manufacturer's CityAccra  
Manufacturer Province/State  
Manufacturer Country/AreaGhana  
Product Code65CBL99  
FDA Product DescriptionNUTRIENT/TONIC N.E.C.  
Refusal Date30-Sep-2009  
FDA DistrictNYK-DO  
Entry/doc/line/sfx AGT-0005049-3/7/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
FALSE   502(a), 801(a)(3); MISBRANDING   The labeling for this article appears to be false or misleading  
N-RX INACT   502(e)(1); 801(a)(3); Misbranding   The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.