A warning has been issued by the FDA regarding a counterfeit version of Avastin 400 mg/16 mL, which may have been purchased and utilized by medical practices in the United States. Chemical analyses of the imitation vials have confirmed the product lacks the active ingredient of Avastin, bevacizumab, which may have resulted in patients not receiving needed therapy.
Packages or vials may be counterfeit if:
- They are labeled with Roche as the manufacturer
- The lot numbers on either the vials or packaging start with B6010, B6011, or B86017
The counterfeit version is labeled as Avastin, manufactured by Roche. However, Genentech markets the only FDA-approved version of Avastin for use in the United States. All authentic Avastin that is FDA-approved for use in the United States is characterized by the following:
- All cartons and vials approved for use in the United States have “Genentech” or “Genentech, a member of the Roche Group” printed on the labels
- The lot number on the carton and vial should be 6 digits with no letters
- The expiry date is formatted as a 3-letter month and 4-digit year, eg, JUL 2014
- The date of manufacture is not printed on the carton or vial
- All the text on the vial labels, cartons, and package inserts is English
Genentech’s Avastin products are safe and effective for their intended uses.
The FDA has determined that 19 medical practices in the United States purchased unapproved cancer medicines (including possibly counterfeit Avastin) from Quality Specialty Products (QSP), which also may be known as Montana Health Care Solutions. Volunteer Distribution in Gainesboro, Tennessee, is a distributor of QSP’s products. The FDA has sent letters to these 19 medical practices to request discontinuing the use of any remaining products from these suppliers. FDA cannot ensure the safety or efficacy of any of these unapproved products.