BE CAREFUL-FAKE AVASTIN DISCOVERED

February 15, 2012 — Counterfeit versions of bevacizumab (Avastin, Genentech) that do not contain the active ingredient are circulating in the United States. Bevacizumab is used in the treatment of several cancers, and the use of these counterfeit products might have resulted in cancer patients not receiving needed therapy, according to the US Food and Drug Administration (FDA).

Actual (Left) and Counterfeit (Right) Vials

The counterfeit products are labeled Avastin (400 mg/16 mL), and Roche is listed as the manufacturer (Roche is the parent company and markets the product outside the United States). Some of the labeling is in French.

In the United States, Avastin is marketed by Genentech (a member company of Roche). On the labels of the FDA-approved product, Genentech is listed as the manufacturer (or as "Genentech, a member of the Roche group"); there is no Roche logo on the packaging or vials. All of the printed information on the vials and packaging is in English, and the lot numbers contain 6 digits with no letters.

The FDA reports that products with batch numbers that start with B6010, B6011, or B86017 could be counterfeit.

Actual (Left) and Counterfeit (Right) Packaging

"The counterfeit product is not safe or effective and should not be used," Roche and Genentech said in a statement. Chemical analysis of counterfeit vials tested to date has confirmed that there is no active ingredient, they said. "We are working with the FDA and law enforcement to aid their evaluations, determine the source of the counterfeit drug, and prevent further distribution."

Report Suspect Products

The FDA noted that 19 practices in the United States purchased unapproved cancer medicines from Quality Specialty Products (QSP), a foreign supplier also known as Montana Health Care Solutions. In addition, some of QSP's products are distributed by Volunteer Distribution in Gainesboro, Tennessee.

Medical practices that have obtained products from Volunteer Distribution and QSP should stop using them and contact the FDA. These products should be retained and securely stored, according to the agency.

To report suspected counterfeit or other suspected products obtained from Volunteer Distribution or QSP/Montana Health Care Solutions, call the FDA Office of Criminal Investigations (OCI) at 800-551-3989, visit the OCI Web site, or email the FDA.