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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 AV3-0024240-9/1/3

Manufacturer FEI1413077
Manufacturer NameBlistex Inc  
Manufacturer Address line 11800 Swift Dr  
Manufacturer Address line 2  
Manufacturer's CityOak Brook  
Manufacturer Province/StateIL  
Manufacturer Country/AreaUnited States  
Product Code53LK06  
Refusal Date13-Feb-2012  
FDA DistrictFLA-DO  
Entry/doc/line/sfx AV3-0024240-9/1/3
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).