• 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 112-6696423-2/1/1


Manufacturer FEI3003601524
Manufacturer NameVetoquinol N.A. Inc.  
Manufacturer Address line 1231 Dundas St W  
Manufacturer Address line 2  
Manufacturer's CityBelleville  
Manufacturer Province/StateOntario  
Manufacturer Country/AreaCanada  
Product Code64LQK58  
FDA Product DescriptionPREGNENOLONE SUCCINATE (GLUCOCORTICOID)  
Refusal Date04-May-2010  
FDA DistrictDET-DO  
Entry/doc/line/sfx 112-6696423-2/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NEW VET DR   501(a)(5), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies. [Adulteration, Section 501(a)(5)]  
-
-