More warning letters sent by FDA over gastric ulcer products

Spread the word
  • 8
  •  
  •  
  •  
  •  
  •  

The US Food and Drug Administration (FDA) has fired off four more warning letters to companies over their marketing of products for stomach ulcers in horses.

The letters to GenericFrontlinePlus.com, Abler Inc, Multivet USA, and Cox Veterinary Laboratory went out the same day as letters to Tri-Star Equine Marketing, Horse PreRace and Horse Gold, Inc over the same issue.

The firms are accused by the FDA of marketing gastric ulcer products as being intended for use in the mitigation, treatment, or prevention of disease in animals, which it says makes them a drug under US federal law.

The products required federal approval, the FDA said.

Each company has been told that it was their responsibility to ensure that all their products complied with the relevant laws and regulations.

The FDA warned that failure to promptly correct the alleged violations may result in enforcement action without further notice.

The companies have 15 working days to tell the FDA of the steps they have taken to comply with the law.

Genericfrontlineplus.com was written to at an address in Dubai; Cox Veterinary Laboratory was written to at a South Carolina address; Abler Inc at an address in New South Wales, Australia; and Multivet USA at a New York address.

At least some of the products at the center of the warning letters appear to contain omeprazole, commonly used to reduce stomach acid output in humans.

Copies of the letters can be found here

Leave a Reply

Your email address will not be published. Required fields are marked *