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Roche and Genentech have been informed that a counterfeit product, labeled as Avastin (bevacizumab), has been distributed in the United States.

The counterfeit product is not safe or effective and should not be used. Chemical analyses of the counterfeit vials tested to date have confirmed the product does not contain the active ingredients for Avastin.

Patient safety is Roche and Genentech's primary concern. We are working with the U.S. Food and Drug Administration (FDA) and law enforcement to aid their evaluations, determine the source of the counterfeit drug, and prevent its further distribution.

Important Information for Healthcare Providers to Identify Suspected Counterfeit Product

If a healthcare provider has any product in their possession that they suspect may be counterfeit, they should immediately contact the FDA's Office of Criminal Investigations (OCI) at 1-800-551-3989 (www.fda.gov/OCI) or Genentech's Product Quality Assurance department at 1-800-334-0290.

It is believed that some product in the United States labeled as Avastin 400 mg/16 mL with the following lot numbers on either the vials or packaging may be counterfeit:

• B86017
• B6011
• B6010

The counterfeit product does not look similar to authentic Avastin that is FDA-approved for the treatment of certain cancers in the United States. In addition, the following is true for all authentic Avastin that is FDA-approved for use in the United States:

• All cartons and vials approved for use in the United States have "Genentech" or "Genentech, a member of the Roche Group" printed on the labels;
• The lot number on the carton and vial should be 6 digits with no letters;
• The expiry date is formatted as a 3-letter month and 4-digit year, e.g. JUL 2014;
• The date of manufacture is not printed on the carton or vial;
• All the text on the vial labels, cartons and package inserts is English.

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