The FDA is warning healthcare professional about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the U.S. The counterfeit version is labeled as Avastin, manufactured by Roche, and does not contain the medicine’s active ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy. Nineteen medical practices in the U.S. 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.
Roche is the company that manufactures Avastin approved for marketing outside of the U.S. 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 U.S. 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.
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,
• Visit OCI’s website at www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm, or
• Email: DrugSupplyChainIntegrity@fda.hhs.gov
Avastin is indicated for metastatic colorectal carcinoma, in combination with 5-FU-based chemotherapy; first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC), in combination with carboplatin and paclitaxel; glioblastoma, as a single agent for patients with progressive disease following prior therapy; and metastatic renal cell carcinoma (mRCC) in combination with interferon alfa.
For more information, visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm291968.htm.