Safety Alerts & Recalls

What does this mean?

Roche and Genentech are working with the U.S. Food and Drug Administration (FDA) and law enforcement to determine the source of the counterfeit drug, and to prevent its further distribution. The FDA has requested that the medical practices stop using any remaining products from QSP, Montana Health Care Solutions, and Volunteer Distribution. Other healthcare providers have been notified to check their supply of Avastin to make sure it is the FDA-approved version.

Based on information to date, FDA has determined that FDA-approved versions of Avastin are available in adequate supply to meet current demand. If you take Avastin, your doctor will continue to have access to a supply of FDA-approved Avastin. However, if you have concerns about this alert, you may wish to talk to your doctor who can address any concerns that you have.

If you take Avastin and you experience any side effects, you should contact your healthcare provider immediately. Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

FDA and Manufacturers Warn about Conterfeit Avastin (Bevacizumab)

Swiss drug maker Roche and the Food and Drug Administration (FDA) are warning healthcare professionals and patients that a counterfeit version of the cancer therapy Avastin was found in the U.S. The counterfeit version is labeled as Avastin, manufactured by Roche but does not contain the medicine's active ingredient, bevacizumab, which my have resulted in patients not receiving needed therapy. The FDA reports that 19 medical practices in California, Texas, and Illinois 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, Tennessee is a distributor of QSP’s products.

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.

Avastin belongs to a class of cancer therapies that interferes with the development of new blood vessels that tumors need to grow. The drug, often used with chemotherapy, is for certain patients with colon, lung and other cancers.

For more information, please visit: more information here

To view a list of doctors who received warnings about purchasing unapproved cancer medicines from QSP, please visit: more information here

Source: FDA
Publication Date: 2012-02-16
Last Updated: 2012-02-16

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