A Lexington pharmacy that makes compound products for horses said it has taken steps to reinforce its safety and quality standards and has cooperated with a federal agency's inquiry into "adverse events earlier this year."
The U.S. recently sent a letter to Wickliffe Veterinary Pharmacy, notifying the firm that tests show its drug products are "adulterated and misbranded" under the federal Food, Drug, and Cosmetic Act.
MITCHELL: FDA Sends Warning Letter to Compounding Firm
"Wickliffe Veterinary Pharmacy, a high-quality provider of customized medicinal solutions for veterinarians, cooperated fully with federal health officials' inquiry into the adverse events involving horses earlier this year," the company said in a statement in response to the letter. "The recent compliance letter issued by the U.S. Food and Drug Administration is related solely to this previous incident. We took prompt action last spring in response to the incident to reinforce our high safety and quality standards for Wickliffe's compounded products. We are preparing a response to the that outlines the steps that we have taken and the quality assurance program that we maintain."
Read more on BloodHorse.com: http://www.bloodhorse.com/horse-racing/articles/86899/compound-pharmacy-has-reinforced-standards#ixzz3B4QZV2Fg
The U.S. recently sent a letter to Wickliffe Veterinary Pharmacy, notifying the firm that tests show its drug products are "adulterated and misbranded" under the federal Food, Drug, and Cosmetic Act.
MITCHELL: FDA Sends Warning Letter to Compounding Firm
"Wickliffe Veterinary Pharmacy, a high-quality provider of customized medicinal solutions for veterinarians, cooperated fully with federal health officials' inquiry into the adverse events involving horses earlier this year," the company said in a statement in response to the letter. "The recent compliance letter issued by the U.S. Food and Drug Administration is related solely to this previous incident. We took prompt action last spring in response to the incident to reinforce our high safety and quality standards for Wickliffe's compounded products. We are preparing a response to the that outlines the steps that we have taken and the quality assurance program that we maintain."
Read more on BloodHorse.com: http://www.bloodhorse.com/horse-racing/articles/86899/compound-pharmacy-has-reinforced-standards#ixzz3B4QZV2Fg
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