The product is not approved by the FDA
of ConsumerAffairs
Tristar Equine Marketing is recalling all lots of Gastrotec, which was previously marketed as an Over-the-Counter (OTC) drug for use in horses, and contains a combination of Omeprazole and Misoprostol.
The FDA has ruled that Gastrotec must have an approved new animal drug application to be legally marketed in the United States. It is not currently approved by the FDA and, as a consequence, Tristar has ceased all production and sales of the product and is recalling it.
There have been no reported adverse events associated with the use of Gastrotec.
The product 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 g/Misoprostol 1.4 mg.
Tristar is notifying its distributors and customers of the recall and will arrange for a return of all recalled product.
Consumers and distributors who have unused Gastrotec should stop using it immediately and contact Tristar to arrange for the return of the product.
Consumers with questions may contact Jerry Glantz by email at info@tristarequine.com from Monday to Friday, 10 am to 4pm, EST.