Equine drug Gastrotec recalled until manufacturer obtains FDA approval


Omeprazole-misoprostol combo marketed to public without safety and efficacy data, FDA says.

Gastrotec, a product labeled for the care of gastric and colonic ulcers in horses, has been recalled. Previously marketed by Tristar Equine Marketing as an over-the-counter drug containing omeprazole and misoprostol, the drug was voluntarily recalled after the U.S. Food and Drug Administration (FDA) alerted the company that its distribution of the product was illegal without an approved new animal drug application. Thus, a recall and halt to all production and sales of Gastrotec will be in effect in the United States until approval by the FDA is obtained.

The FDA reports that there have been no known incidents of adverse events in association with the product, but its safety and efficacy has not been established. Veterinarians and horse owners are directed to stop use of the product immediately and contact Tristar at info@tristarequine.com to arrange for the return of the product. According to the FDA, Gastrotec is a paste that is package in a boxed tube bearing the name "Gastrotec, Omeprazole 2.28g/Misoprostol 1.4mg."

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