BETHESDA, MD 15 February 2012—Genentech announced yesterday that a counterfeit version of Avastin 400 mg/16 mL that does not contain bevacizumab, the true product's active ingredient, has been distributed in the United States.
According to Genentech and FDA, packaging for the counterfeit material bears lot numbers that begin with B6010, B6011, or B86017 and displays the Roche logo, which does not appear on the genuine product.
Genentech manufactures Avastin for parent company Roche. Labels for legitimate containers of Avastin bear the word "Genentech" or the phrase "Genentech, a member of the Roche Group," according to the companies.
Other distinguishing features of the packaging for legitimate Avastin include the presence of a six-digit lot number that contains no letters and an expiration date consisting of three letters designating the month and a four-digit year designation. In addition, the manufacturing date is not printed on cartons or vials of Avastin, and all text on the product's labels, packaging, and package inserts is in English.
Genentech and FDA emphasized that the counterfeit drug is neither safe nor effective, and patients treated with it did not receive effective therapy.
Bevacizumab, a vascular endothelial growth factor inhibitor, is indicated for the treatment of several different kinds of cancer.
FDA on February 10 sent letters to 19 medical practices—16 in California, 2 in Texas, and 1 in Illinois—that might have obtained counterfeit Avastin or other unapproved medications from a "foreign supplier" that the agency identified as Quality Specialty Products (QSP). According to FDA, the company, which may also be known as Montana Health Care Solutions, distributes its products through Volunteer Distribution of Gainesboro, Tennessee.
The letters state that QSP's products, which consist largely of injectable drugs, "may be from unknown sources, may have unknown ingredients, may be counterfeit, or may not have been manufactured, transported or stored under proper conditions required by U.S. law, regulations, and standards."
The letters, all but one of which were addressed to individual physicians, also warned the medical offices that purchasing medication from non-U.S. sources violates the Federal Food, Drug, and Cosmetic Act and other federal statutes.
The agency noted in the letters that none of the medications sold by QSP, including Avastin, are in short supply, and all may be obtained from legitimate sources.
FDA instructed the medical offices to immediately stop administering the counterfeit Avastin to patients and to retain and secure any other products purchased from QSP until the agency decides on the appropriate disposition of those products.