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Counterfeit Version of Avastin in US Distribution, FDA Warns
FDA is warning health care providers and patients about a counterfeit version of Avastin® 400 mg/16 mL, which may have been purchased and used by some medical practices in the United States. Avastin is an injectable medicine used to treat cancer and is administered to patients in clinics, hospitals, and doctors’ offices. The counterfeit version of Avastin does not contain the medicine’s active ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy.
Related to this warning, FDA has issued letters to 19 medical practices in the US that purchased unapproved cancer medicines that may include the counterfeit Avastin. Packages or vials may be counterfeit if they are labeled with Roche as the manufacturer, and/or display batch numbers that start with B6010, B6011, or B86017. FDA explains that Roche is the company that manufactures Avastin approved for marketing outside of the US. Further, Roche conducted laboratory tests that confirmed the counterfeit version of Avastin.
FDA indicates that the only FDA-approved version of Avastin for use in the US is marketed by Genentech (a member company of Roche), and that this version does not include the Roche logo on the packaging or vials. In addition, Genentech’s FDA-approved version of Avastin vials and packaging have a six-digit numeric batch number and expiration dates in a three-letter month and four-digit year format (eg, JAN 2014). Genentech’s Avastin products are safe and effective for their intended uses.
The 19 medical practices that were sent letters by FDA purchased unapproved cancer medicines, and, potentially, the counterfeit Avastin, from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions. Volunteer Distribution in Gainesboro, TN is a distributor of QSP’s products. FDA has requested that the medical practices stop using any remaining products from these suppliers, retain and securely store the products, and contact the FDA’s Office of Criminal Investigations (OCI) by calling 800/551-3989 or by completing a report on the FDA OCI Web site.
Additional information is available in the FDA drug safety communication.
