A firm warned by U.S. Food and Drug Administration (FDA) to cease selling the equine ulcer product Gastrotec without that agency’s approval has voluntarily recalled that product.

In October, Tristar Equine Marketing LLC was one of several companies that received warning letters relative to their marketing of various equine ulcer products deemed by the FDA to be “intended for use in the mitigation, treatment, or prevention of disease in animals, which makes (them) drugs under the Federal Food, Drug and Cosmetic Act.”Under the act drugs intended for use in animals “require an approved new animal drug application unless they are generally recognized as safe and effective,” the warning letters said.

Specifically, Tristar was warned against internet marketing of Gastrotec, which was marketed Gastrotec as an over-the-counter drug for use in horses, and contains a combination of omeprazole and misoprostol.

UlcerGard (omeprazole) and GastroGard (omeprazole) are the only FDA-approved products for the prevention and treatment of equine stomach ulcers.

On Dec. 12, Tristar voluntarily recalled all lots of Gastrotec down to the consumer level, according to a statement on the FDA website.

Tristar representative Jerry Glantz was unavailable for comment.

The press release stated that Tristar notified by email its distributors and customers of the voluntary recall and the firm will arrange for the return of the recalled product. Consumers and distributors that have unused Gastrotec should stop using