February 16, 2012
FDA has issued a safety alert to notify healthcare professionals and patients of counterfeit Avastin 400 mg/16 mL products, which do not contain the active drug bevacizumab. The counterfeit products are from a foreign supplier, Quality Specialty Products (QSP), also known as Montana Health Care Solutions. Products distributed by Volunteer Distribution may also be counterfeit. The counterfeit products may have “Roche” as the manufacturer on the vial or package, contain lot numbers starting with B6010, B6011, or B86017, or have labels and packaging not printed in English. Authentic FDA-approved Avastin (bevacizumab) products are printed in English with “Genentech” as the manufacturer, 6-digit lot numbers without letters, expiration dates printed as a 3-letter month and 4-digit year, and do not have the manufacturing date on the label.
FDA has identified19 centers that have purchased the counterfeit products. Stop using the affected products immediately. Report suspicious or counterfeit products to FDA's Office of Criminal Investigations (OCI) at 800-551-3989, OCI's Web site (www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm), or email DrugSupplyChainIntegrity@fda.hhs.gov.
Report any related adverse events to FDA’s MedWatch Adverse Event Reporting program online: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
Additional information is available at the following links:
- FDA MedWatch
- FDA Counterfeit Version of Avastin in U.S. Distribution
- FDA Letters to Doctors
- Genentech Press Statement (includes pictures of authentic and counterfeit products)
February 16, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.