OTC Horse Medication Gastrotec Recalled for Lacking FDA Approval
Tristar Equine Marketing is recalling an over-the-counter medication for horses because it is not approved for sale by the U.S. Food and Drug Administration (FDA).
The company stopped production and pulled the product when it received information from the FDA that an animal-drug application for Gastrotec must be approved before it can be sold or manufactured in the U.S.
Gastrotec contains a combination of Omeprazole and Misoprostol and is used to car for gastric and colonic ulcers in horses.
Without a formal application, the FDA said that the safety and efficacy of the product hasn't been established. To date, there have been no reported adverse events associated with the product.
Consumers should contact their veterinary healthcare provider if they have experienced any problems that may be related to the use of this drug 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.
For more information about the recall, consumers can contact Jerry Glantz by email at email@example.com from Monday to Friday, 10 am to 4pm, EST.