Warrenton Horse Works, LLC

Cox Voluntarily Recalls Equine Ulcer Drug

The manufacturer of an over-the-counter equine ulcer treatment has voluntarily recalled and ceased production of the product because it is not approved by the U.S. Food and Drug Administration (FDA).

Last fall, several companies 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.

On Jan. 23, the FDA posted a written statement concerning the voluntary recall of Gastroade Xtra on their website. Manufactured by Cox Veterinary Laboratory Inc., the omeprazole paste was packaged in a 32 mL tube bearing the name Gastroade Xtra, Omeprazole 2.28g. Affected lots include Batch 0052 (UPC 091037382986), manufactured 5/29/2014.

"This recall has been initiated due to information from the FDA that Gastroade Xtra must have an approved new animal drug application to be legally marketed in the United States," Cox's statement said. "Gastroade Xtra is not approved by the FDA. In addition, some lots may be sub-potent and pose a risk of continued ulceration. As a consequence, Cox Veterinary Laboratory has ceased all production and sales of Gastroade Xtra and is recalling the product..

"Because the FDA has not approved Gastroade Xtra, the safety and efficacy of the product has not yet been established," the statement continued. "To date, however, there have been no reported adverse events associated with the use of Gastroade Xtra."

Consumers and distributors that have unused portions of Gastroade Xtra should stop using the product immediately and arrange for its return to Cox Veterinary Laboratory, the statement said. Consumers with questions about the voluntary recall can contact Cox's Jeanne Buffington at jeanne@coxvetlab.com

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