The following FDA warning is vital information for all hospital and Medical Practice Risk Managers: the FDA has issued a warning about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States. The counterfeit version is labeled as Avastin, manufactured by Roche and does not contain the medicine’s active ingredient, bevacizumab, which my have resulted in patients not receiving needed therapy.
19 medical practices in the United States purchased unapproved cancer medicines from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions. Volunteer Distribution in Gainesboro, Tennessee is a distributor of QSP’s products.
Avastin is an injectable medicine used to treat cancer and is administered to patients in clinics, hospitals, and doctors’ offices. Roche is the company that manufactures Avastin approved for marketing outside of the United States. Roche conducted laboratory tests that confirmed the counterfeit version of Avastin. Packages or vials may be counterfeit if they:
-are labeled with Roche as the manufacturer
-display batch numbers that start with B6010, B6011 or B86017
The only FDA-approved version of Avastin for use in the United States is marketed by Genentech, a member company of Roche. The FDA-approved version does not include the Roche logo on the packaging or vials. FDA approved versions of these medicines are available in adequate supply to meet demand.
CORE Risk Services, Inc. is committed to loss prevention and is available to hospitals, medical practices, ambulatory centers, and long term care facilities to help develop and maintain their loss prevention and control programs.
RECOMMENDATION: 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. To report suspect counterfeit products and other suspect products obtained from Volunteer Distribution or QSP/Montana Health Care Solutions:
Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989,