Equine veterinarians urged to report problems with Gastroade Xtra

Equine veterinarians urged to report problems with Gastroade Xtra

Some lots of OTC omeprazole drug may be subpotent; product lacks FDA approval.
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Jan 27, 2015
By dvm360.com staff

Previously marketed as an over the counter drug for horses, Gastroade Xtra has been voluntarily recalled by its manufacturer, Cox Veterinary Laboratory. The recall was initiated after notification from the U.S. Food and Drug Administration (FDA) that the product must have a new animal drug application to be legally marketed in the United States. Gastroade Xtra, which contains omeprazole, is currently not approved by the FDA.

Cox Veterinary Laboratory has also ceased production and sales of Gastroade Xtra, the FDA says in a release, because in addition to pending approval, some lots of the drug may be subpotent and pose a risk of continued ulceration. Although there have been no reported problems associated with Gastroade Xtra, the FDA says that without approval, it cannot confirm the safety and efficacy of the product.

Gastroade Xtra, a paste packaged in 32-ml tubes, is marketed for the care of gastric ulcers in horses. Distributors and customers should receive a letter sent certified mail from Cox Veterinary Laboratory detailing the recall and arrangements for a return of the recalled product. Affected lots include Batch 0052 (UPC 091037382986) manufactured May 29, 2014.

Questions regarding the recall of Gastroade Xtra may be directed to Jeanne Buffington at [email protected]. Horse owners, caretakers and veterinarians are encouraged to report adverse events, including ineffectiveness, to the FDA at fda.gov. Complaints may also be reported by calling a consumer complaint coordinator at an FDA district office or by filing a veterinary adverse drug reaction report.