The U.S. Food and Drug Administration has sent a letter to a Lexington pharmaceutical firm that compounds drugs for horses notifying the firm that tests show its drug products are "adulterated and misbranded" under the federal Food, Drug, and Cosmetic Act.
In a letter to Wickliffe Pharmaceutical Inc. and its president/owner Jacqueline S. Bernard, the FDA's district office in Cincinnati, Ohio, said an investigation of the pharmacy was initiated after the deaths of two horses in Kentucky after they were administered an oral paste containing toltrazuril and pyrimethamine compounded by the pharmacy, While the investigation was underway, the letter states, the agency received a report that eight horses in Florida had suffered adverse reactions after they were treated with a "suspension drug product compounded by your pharmacy that also contained toltrazuril and pyrimethamine."
Subsequent tests of two samples obtained from the pharmacy showed concentration levels between 81-83% of the declared concentration levels. In another test, the drugs contained 3.74% and 2,380% of the declared concentration levels.
Wickliffe has been sued by owners of at least three Thoroughbreds hospitalized after receiving a compounded drug from the company alleging their horses at an Ocala, Fla., training center were hospitalized after receiving a compounded drug to treat or prevent equine protozoal myeloencephalitis.
"Please note that the violations cited in this letter are not intended to be an all-inclusive list of violations at your facility," the letter continues. "You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in legal action without further notice, including, without limitation, seizure and injunction."
Wickliffe was given 15 working days from receipt of the letter dated Aug. 14 in which to notify the FDA office in writing of specific steps taken to correct violations or, if unable to complete corrective action within that time period, to state the reason for the delay and the time within which the correction will be completed.
FDA Warning Letter