FDA Issues Safety Alert Regarding Fraudulent Botox
Posted on Health Care Law News April 29, 2013 by author
The Food and Drug Administration (FDA) issued a safety alert on April 26, 2013 warning health care providers and the public about fraudulent Botox being sold in the United States. The fraudulent Botox is being peddled to physicians through blast faxes which offer Botox at discount prices. The faxes list the names of the seller as “Online Botox Pharmacy,” “Online Botox.com,” and “Online Botox.”
The product is contained in counterfeit boxes that closely match legitimate Botox that is FDA approved for sale in the United States. Inside the boxes, however, is foreign labeled product.
The FDA’s alert does not state whether the foreign labeled product is legitimate Botox intended for the foreign market, or whether the product itself is counterfeit. Allergan manufactures identical Botox for use in the United States and foreign markets, but places different labels on the vials, and packages the vials in different boxes.
According to the FDA, the counterfeit boxes list the contents as “Botulinum Toxin Type A” instead of “OnabotulinumtoxinA” as appears on legitimate FDA approved Botox. Also, the lots numbers and expiration dates on the counterfeit boxes do not match the vials contained in the boxes.
Physicians who have purchased suspect Botox product should properly dispose of the product. The purchase of non-FDA approved drugs, devices and biologics is a violation of Federal law, and can lead to administrative action against the physician, and in extreme cases, can lead to criminal prosecution.
The attorneys at Nicholson & Eastin, LLP represent health care providers and medical product distributors in FDA regulatory actions, as well as licensure investigations.