Tristar Equine Marketing LLC is voluntarily recalling all lots of Gastrotec. Gastrotec was previously marketed by Tristar as an over-the-counter drug for use in horses. It contains a omeprazole and misoprostol.
The 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. To date, the company states, there have been no reported adverse events associated with the use of Gastrotec.
Gastrotec is labeled for the care of equine ulcers and sold in a paste form. Consumers should stop using this product immediately and contact Tristar to arrange for the return of the product. Contact your distributor/retailer for further information on returns or email Tristar at email@example.com
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.