WASHINGTON, Feb. 17 (UPI) -- U.S. Food and Drug Administration officials sent letters to healthcare professionals and patients, warning of a counterfeit version of Avastin 400mg/16mL.
Avastin is an injectable medicine used to treat cancer and is administered to patients in clinics, hospitals and doctors' offices. The counterfeit version does not contain the medicine's active ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy, FDA officials said.
In a related action, the FDA has issued letters to 19 medical practices in the United States that purchased unapproved cancer medicines that may include the counterfeit Avastin. The counterfeit version is labeled as Avastin, manufactured by Roche.
Roche conducted laboratory tests that confirmed the counterfeit version of Avastin. Packages or vials may be counterfeit if they were labeled with Roche as the manufacturer and 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.
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 (e.g., JAN 2014). Genentech's Avastin products are safe and effective for their intended uses, the FDA said.
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