• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Import Refusal Report

  • Print
  • Share
  • E-mail
-

Refusal Details as Recorded in OASIS by FDA

for Refusal UPS-5947408-8/1/1/B


Manufacturer FEI3007429774
Manufacturer NameSlovenska Posta A.S.  
Manufacturer Address line 1Tomasikova 54  
Manufacturer Address line 2  
Manufacturer's CityBratislava 3bratislava 3  
Manufacturer Province/State  
Manufacturer Country/AreaSlovakia  
Product Code65VCA56  
FDA Product DescriptionZOLPIDEM TARTRATE (SEDATIVE)  
Refusal Date17-Aug-2010  
FDA DistrictCIN-DO  
Entry/doc/line/sfx UPS-5947408-8/1/1/B
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
DIRECTIONS   502(f)(1), 801(a)(3); MISBRANDING   The article appears to lack adequate directions for use.  
-
-