WASHINGTON (AP) - Federal regulators have warned more than 350 medical practices nationwide and six in Kentucky that Botox they may have received from a Canadian supplier is unapproved and could be counterfeit or unsafe.
The Food and Drug Administration said in a letter sent last month and released last week that batches of the wrinkle treatment shipped by suppliers owned by pharmacy Canada Drugs have not been approved by the FDA and that the agency cannot assure their effectiveness or their safety.
Among the 350 office receiving warning letters from the FDA are Dr. Williams Jenkins of Lexington and Dr. Timothy Lavender of Pikeville.
The FDA said Canada Drugs was previously tied to shipping unapproved and counterfeit cancer drugs.
The agency warns doctors about of buying drugs from sources other than licensed U.S. pharmacies. This is the fifth warning the agency has made this year about foreign suppliers providing unapproved drugs.