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Avastin - counterfeit injections in the USA

17 February 2012

The United States Food and Drug Administration (USFDA) has advised that it has found instances of medical clinics in the United States importing a counterfeit version of the injectable drug bevacizumab (brand name Avastin). The counterfeit version did not contain the active ingredient as was claimed and may have resulted in patients not receiving their needed therapy.

The counterfeit product was made available in 400mg/16ml vials. The counterfeit product in the USA is said to have included French and Arabic lettering on the packaging and had batch numbers that start with B6010, B6011 or B86017.

The Therapeutic Goods Administration (TGA) has not received any reports to date of similar counterfeit Avastin vials being found in Australia.

About Avastin

Avastin is approved in Australia for use in the treatment of a number of cancers including metastatic bowel cancer, some breast cancers, non-small cell lung cancer, some cancers of the kidney and some brain cancers.

400mg/16 ml vials are one of the two registered presentations of Avastin in Australia.

Information for healthcare professionals

Healthcare professionals are reminded that the Therapeutic Goods Act provides for very severe penalties, including imprisonment, for the importation or supply of counterfeit medicines in Australia.

The TGA has sent information on counterfeit Avastin to hospital and community pharmacies.

Report counterfeit medicines and medical devices

If you are worried about counterfeit medicines or medical devices, and want to report an issue, you can report the matter to the TGA:

Content last updated: Friday, 17 February 2012

Web page last updated: Monday, 25 June 2012

URL: http://www.tga.gov.au/safety/alerts-medicine-avastin-120217.htm