Gastrotec Recalled after FDA Warning stock photo

Gastrotec Recalled after FDA Warning

A recall has been issued for an equine ulcer product. Tristar Equine Marketing is voluntarily recalling all lots of Gastrotec.
Gastrotec was marketed as an over-the-counter drug for “gastric and colonic ulcers in horses.” The combination paste contains Omeprazole and Misoprostol, but was not approved by the FDA.
UlcerGard and GastroGard are the only FDA approved products to prevent or treat equine stomach ulcers.

In late October, Tristar received a FDA Warning Letter. Tristar states it has ceased all production and sales of Gastrotec. “This recall has been initiated due to information from the FDA that Gastrotec must have an approved new animal drug application to be legally marketed in the United States.”

There have been no reported adverse events associated with the use of product, according to the company. Consumers and distributors that have unused Gastrotec should stop using the product and contact Tristar to arrange for a return of the product.

Questions regarding the recall should be addressed to info@tristarequine.com.