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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 BAO-0013928-7/1/2

Manufacturer FEI3008431877
Manufacturer NameNovartis Consumer Health C/O Ohl  
Manufacturer Address line 11101 Whitaker Rd  
Manufacturer Address line 2  
Manufacturer's CityPlainfield  
Manufacturer Province/StateIN  
Manufacturer Country/AreaUnited States  
Product Code66CAH99  
FDA Product DescriptionSTOOL SOFTENER N.E.C.  
Refusal Date22-Sep-2010  
FDA DistrictFLA-DO  
Entry/doc/line/sfx BAO-0013928-7/1/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).