FDA WARNING_LETTER - Wickliffe Pharmaceutical Inc - May 22, 2014

On April 29 to May 22, 2014, the FDA inspected Wickliffe Pharmaceutical, Inc. following the deaths of two horses in Kentucky and adverse reactions, including two deaths, in eight horses in Florida, all linked to compounded oral paste or suspension products containing toltrazuril and pyrimethamine.

The investigation revealed that compounded animal drug products were adulterated and misbranded. A paste (Lot #25-03-2014@25) labeled with toltrazuril 227mg/ml and pyrimethamine 340mg/ml was found to contain 80-81% of declared toltrazuril and 82-83% of declared pyrimethamine. A suspension (Lot #28-03-2014@44) labeled with toltrazuril 416mg/ml and pyrimethamine 17mg/ml was found to contain 3.74% of declared toltrazuril and 2380% of declared pyrimethamine.

These deviations in strength caused the products to be adulterated under Section 501(c) of the FD&C Act [21 U.S.C. § 351(c)] and misbranded under Section 502(a) [21 U.