• 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 XXX-0126906-8/1/5


Manufacturer FEI3004527544
Manufacturer NameLaboratorios Farmaceuticos  
Manufacturer Address line 1Unknown Street  
Manufacturer Address line 2  
Manufacturer's CityBogota  
Manufacturer Province/State  
Manufacturer Country/AreaColombia  
Product Code61LDB13  
FDA Product DescriptionWARFARIN SODIUM (ANTI-COAGULANT)  
Refusal Date11-Oct-2005  
FDA DistrictFLA-DO  
Entry/doc/line/sfx XXX-0126906-8/1/5
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
PERSONALRX   502(a) & (f)(1), 801(a)(3); MISBRANDING   The article appears to be a drug which requires a prescription from your doctor.  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
-
-