FDA WARNING_LETTER - Rapid Equine Solutions, LLC - August 09, 2019

An FDA inspection of Rapid Equine Solutions, LLC from July 22 - August 9, 2019, was initiated following the death of three horses administered a compounded toltrazuril/pyrimethamine oral paste. The inspection revealed significant violations, leading to a Warning Letter. The firm's animal drugs were found to be adulterated under section 501(a)(2)(A) of the FD&C Act due to insanitary conditions. Furthermore, the toltrazuril/pyrimethamine paste (Lot#20190509-11) was adulterated under section 501(c) because its strength differed significantly from its label, with toltrazuril at 3% and pyrimethamine at over 1800% of declared concentrations. This product was also misbranded under section 502(a) as its labeling was false and misleading. The introduction of such adulterated or misbranded drugs into interstate commerce is prohibited by sections 301(a) and 301(k). While the firm voluntarily recalled the product and submitted corrective actions, including revised SOPs and pest control, the FDA found these responses inadequate due to a lack of supporting documentation and noted that a secondary check was already in place during the original mix-up. The firm must promptly correct all violations and provide documented evidence within fifteen working days to avoid potential legal action, including seizure or injunction.