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 firstname.lastname@example.org 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.