SAFETY ALERT: FDA Warns of Counterfeit Avastin (Bevacizumab), Issues Letters to 19 Medical Practices
The U.S. Food and Drug Administration is warning healthcare professionals and patients that a counterfeit version of Avastin (bevacizumab) 400mg/16mL was purchased and may have been used by 19 medical practices — 16 in California , 1 in Illinois, and 2 in Texas.
“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,” according to the FDA. In addition, the counterfeit product packaging does not resemble authentic Avastin.
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 medical practices 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. The FDA recommends that 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.
- Email: DrugSupplyChainIntegrity@fda.hhs.gov