FDA WARNING_LETTER - Cox Veterinary Laboratory, Inc.

The FDA issued a Warning Letter to Cox Veterinary Laboratory, Inc. regarding their product, Gastroade Xtra. The FDA reviewed the firm's website (coxvetlab.com) and tested product samples.

Gastroade Xtra is deemed an unapproved new animal drug because its intended use, as indicated by website and label statements (e.g., "prevention of stomach ulcers in horses," "Omeprazole works against the production of acid"), is for the mitigation, treatment, or prevention of disease in animals. This classifies it as a drug under section 201(g)(1)(B) of the FD&C Act. As a new animal drug, it requires an approved new animal drug application, conditional approval, or index listing, which Gastroade Xtra lacks. Consequently, it is considered unsafe under section 512(a)(1) and adulterated under section 501(a)(5) of the FD&C Act.

Furthermore, FDA testing revealed the product's strength differed from its label claim; it was found to be sub-potent at 36.3% of the stated omeprazole potency. This constitutes adulteration under section 501(c) of the FD&C Act.

The firm must correct these violations within fifteen working days and notify the FDA in writing, providing documentation of corrective actions or a timeline for completion. Failure to comply may result in enforcement actions, including product