Feb 14, 2012 -- The U.S. Food and Drug Administration (FDA) is warning health care professionals and patients about a counterfeit version of Avastin 400mg/16mL, 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.
In a related action, 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 is the company that manufactures Avastin approved for marketing outside of the United States.
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 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 6-digit numeric batch number and expiration dates in a 3-letter month and 4-digit year format (e.g., JAN 2014). Genentech's Avastin products are safe and effective for their intended uses.
Statement Update Issued: July 10. 2012
FDA has issued letters to medical practices in the United States that purchased unapproved medications that may include the counterfeit versions of Avastin or Altuzan. The medical practices purchased unapproved medications from foreign distributors such as Clinical Care, Quality Specialty Products (QSP), Montana Health Care Solutions, and Bridgewater Medical.
Update February 5, 2013
On February 5, 2013, the FDA posted a health practitioner warning about this latest counterfeit version of the cancer treatment Avastin.
The is the fake version of Roche Avastin.
The counterfeit version of Avastin does not contain the medicine's active ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy
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