FDA: Equine Ulcer Product Marketing Leads to Warnings for Horse Companies

Gastroade Xtra Recalled after FDA Warning

A recall has been issued for an equine ulcer product that was found sub-potent by the FDA. Cox Veterinary Labratory, Inc. is voluntary recalling Gastroade Xtra.

Gastroade Xtra was marketed as an over-the-counter drug for the “care of gastric ulcers” in horses and contains Omeprazole. Gastroade Xtra is not approved by the FDA. In addition, some lots may be sub-potent and pose a risk of continued ulceration, according to the company.
UlcerGard and GastroGard are the only FDA approved products to prevent or treat equine stomach ulcers.
In November, the FDA sent a Warning Letter to Cox Veterinary Lab. The company has ceased all production and sales of Gastroade Xtra. It states there have been no reported adverse events associated with the product’s use.
Affected lots include Batch 0052 (UPC 091037382986) manufactured on May 29, 2014. Consumers and distributors that have unused Gastroade Xtra should stop using the product and contact Jeanne Buffington at jeanne@coxvetlab.com to arrange for a return.
Last month, Gastrotec also issued a voluntary recall of its product. The FDA began cracking down on unapproved equine ulcer products in November.