In late October, Tristar received a FDA Warning Letter. Tristar states it has ceased all production and sales of Gastrotec. “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.”
There have been no reported adverse events associated with the use of product, according to the company. Consumers and distributors that have unused Gastrotec should stop using the product and contact Tristar to arrange for a return of the product.
Questions regarding the recall should be addressed to firstname.lastname@example.org.