A South Carolina company is voluntarily recalling its over-the-counter product called Gastroade Xtra, marketed for the prevention of stomach ulcers, because it does not have the required federal approval.
Cox Veterinary Laboratory, Inc. is recalling the product which was previously marketed by the firm as an over-the-counter drug for use in horses. It contains Omeprazole. Affected lots include Batch 0052 (UPC 091037382986), manufactured on May 29 last year.
The recall was initiated after the United States Food and Drug Administration (FDA) told the company that Gastroade Xtra must have an approved new animal drug application to be legally marketed in the US.
Gastroade Xtra is not approved by the FDA. In addition, some lots may be sub-potent and pose a risk of continued ulceration.
As a consequence, the company has ceased all production and sales of Gastroade Xtra and is recalling the product.
Because the FDA has not approved Gastroade Xtra, the safety and efficacy of the product has not yet been established. However, to date, there have been no reported adverse events associated with its use.
Gastroade Xtra is labeled for the care of gastric ulcers in horses. It is a paste packaged in a 32ml tube. It bears the name Gastroade Xtra, Omeprazole 2.28g.
Cox Veterinary Laboratory is notifying its distributors and customers by letter and through a press release. It will arrange for a return of all recalled product.
Consumers and distributors with unused product should stop using it and contact the company to arrange its return.
Consumers should contact their veterinary healthcare provider if they have experienced any problems that may be related to the use of this drug product.
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