OTC Ulcer Medication for Horses Recalled for Lacking FDA Approval

OTC Ulcer Medication for Horses Recalled for Lacking FDA Approval
January 26, 2015

An over-the-counter medication to treat ulcers in horses has been recalled for lacking approval from the U.S. Food and Drug Administration (FDA).

Cox Veterinary Laboratory recalled Gastroade Xtra after receiving notification that a new animal-drug application must be approved by the agency before it can be legally marketed in the U.S. The company also believes that some lots may not be potent enough and risk continued ulceration in horses.

Although there have been no reported adverse events associated with the use of the medication, its safety and efficacy needs to be established by the FDA.

Gastroade Xtra is a paste that is packaged in a 32-ml tube bearing the name Gastroade Xtra, Omeprazole 2.28g. Affected lots include Batch 0052 (UPC 091037382986) manufactured 5/29/2014.

Consumers and distributors that have unused Gastroade Xtra should stop using it immediately and contact Cox Veterinary Laboratory to arrange for the return.

Information on reporting adverse events for approved or unapproved animal drugs can be found here.

Complaints about approved and unapproved animal drug products can be reported by calling a consumer complaint coordinator, within your FDA District Office or by filing a Veterinary Adverse Drug Reaction report.

Questions regarding this voluntary recall should be addressed to Jeanne Buffington by email at jeanne@coxvetlab.com.