Tristar Equine Marketing, LLC announced today that it is voluntarily recalling all lots of its Gastrotec product down to the consumer level. Gastrotec was previously marketed by Tristar as an over-the-counter ("OTC") drug for use in horses, and contains a combination of Omeprazole and Misoprostol.
This recall has been initiated following information from the US Food and Drug Administration (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 and colonic ulcers in horses. Gastrotec is a paste that is packaged in a boxed tube bearing the name Gastrotec, Omeprazole 2.28 mg/Misoprostol 1.4 mg.
Aided with the information provided by the FDA, Tristar is notifying its distributors and customers of this voluntary recall by email directly and through this press release. Tristar will arrange for a return of all recalled product.
Consumers and distributors who have unused Gastrotec should stop using this product immediately and contact Tristar to arrange for the return of the product.
Tristar is requesting that questions regarding this voluntary recall be addressed to Jerry Glantz by email to info(at)tristarequine(dot)com from Monday to Friday, 10 a.m. to 4 p.m., eastern time.
Consumers should contact their veterinary healthcare providers if they have experienced any problems that may be related to the use of this drug product.
Tristar noted that the recall is being conducted with the knowledge of the U.S. Food and Drug Administration. According to the FDA website, Tristar received a letter dated October 29, 2014 requesting documentation of the company's products compliance with FDA regulations within 15 days.
Note: On November 14, the FDA publicly announced that it had notified the manufacturers of nine products marketed for equine ulcers of their need to comply with federal regulations. Tristar's recall is the first to come to the attention of The Jurga Report.