Tristar Equine Issues Voluntary Recall of Gastrotec

ucm426948

Tristar Equine Marketing, LLC is voluntarily recalling all lots of Gastrotec down to the consumer level. Gastrotec was previously marketed by Tristar as an OTC drug for use in horses, and contains a combination of Omeprazole and Misoprostol. 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. Gastrotec is not approved by the FDA. As a consequence, Tristar has ceased all production and sales of Gastrotec and is recalling the product.

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

Gastrotec is labeled for the care of gastric & colonic ulcers in horses. Gastrotec is a paste that is packaged in a boxed tube bearing the name Gastrotec, Omeprazole 2.28 g/Misoprostol 1.4 mg.

Aided with the information provided by the FDA, Tristar is notifying its distributors and customers by an email, directly and through this press release of this voluntary recall. Tristar will arrange for a return of all recalled product. Consumers and distributors that have unused Gastrotec should stop using this product immediately and contact Tristar to arrange for the return of the product.

Questions regarding this voluntary recall should be addressed to Jerry Glantz by email at info@tristarequine.com from Monday to Friday, 10 am to 4pm, EST.

Consumers should contact their veterinary healthcare provider if they have experienced any problems that may be related to the use of this drug product.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

University of Florida

IFAS

As part of both the Institute of Food and Agricultural Sciences and UF Health, Veterinary Medicine is dedicated to advancing animal, human and environmental health through teaching, research, extension and patient care.

IFAS footerblock

University of Florida

Animal Hospitals

Need animal care? Visit the UF Small Animal and Large Animal Hospitals. From dogs, cats, birds and exotics to horses, cattle, llamas, pigs and many other large farm or food animals, our experienced veterinary staff is ready to assist.

animalhospitalsfooter

Syndicated Podcast

Animal Airwaves

Animal Airwaves is a daily radio series that features one-minute segments relating to animal health, ranging from insights into animal behavior to veterinary patient care breakthroughs and trends.

animalairwavesfooter