Medical practices that purchase Botox may unwittingly be purchasing a fraudulent product not approved by the U.S. Food and Drug Administration for sale in the United States, according to an April 26 drug safety alert issued by the agency.
The products, which are solicited through “blast faxes” and sold below market price, consist of a counterfeit outer carton and a vial labeled as a foreign version of Botox. Sold by unlicensed suppliers outside the U.S. supply chain, these products may not be up to FDA standards for manufacturing, quality, storage, and handling.
The company uses three names, “Online Botox Pharmacy,” “Onlinebotox.com,” and “Onlinebotox,” though at the time the FDA issued its alert, the company did not appear to be selling over the Internet. Purchased items arrive bearing a U.S. return postal address, which is often the case with companies that sell fraudulent products to medical practices.
According to the FDA, “medications purchased from foreign or unlicensed sources may be misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe. Medical practices that purchase and administer illegal and unapproved medications from foreign sources are putting patients’ health at risk, as patients may not be getting proper treatment.”