FDA WARNING_LETTER - Vetoquinol N.-A. - May 19, 2016

On May 13 and May 16-19, 2016, an FDA inspection of Vetoquinol N.-A. Inc.'s animal drug manufacturing facility in Princeville, Quebec, Canada, revealed violations. The firm is marketing unapproved new animal drugs: Ear Cleansing Solution and Clotrimazole Solution, via www.vetoquinolusa.com, and Tomlyn® Ear Cleaner, via www.tomlyn.com, a division of the firm.

These products are deemed "drugs" under section 201(g)(1)(B) of the FD&C Act due to their intended use in mitigating, treating, or preventing animal diseases, as evidenced by website claims. They are classified as "new animal drugs" under section 201(v) because they lack general recognition among experts for safety and effectiveness.

The products are not subject to an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act. Consequently, they are considered unsafe per section 512(a) and adulterated under section 501(a)(5) of the FD&C Act.

The FDA requires a written response within fifteen working days detailing corrective actions. Failure to comply may result in enforcement actions, including product seizure and/or injunctions.