Some cancer patients may not get proper treatment because a counterfeit version of the drug sold as Avastin 400mg/16mi has been purchased by as many as 19 medical practices in the United States, FDA warned Wednesday.
Some cancer patients may not get proper treatment because a counterfeit version of the drug sold as Avastin 400 mg/16 mi has been purchased by as many as 19 medical practices in the United States, FDA warned.
Avastin is used to treat certain types of cancer, including lung cancer and cancer of the colon (large intestine) or rectum that has spread to other parts of the body. The counterfeit drug does not contain the medication’s active ingredient, bevacizumab, FDA said.
FDA said the phony version is labeled as Avastin, with the Roche logo on the packaging. Genentech, a division of Roche, markets the version of Avastin approved for use in the United States.
“Roche is the company that manufactures Avastin approved for marketing outside of the United States,” FDA said in a news release. “Roche conducted laboratory tests that confirmed the counterfeit version of Avastin.”
An FDA spokesperson said there is no evidence that the counterfeit version has been given to patients, according to Fox News.
FDA said in its release that vials or packages of Avastin that display batch numbers starting with B6010, B6011 or B86017 are likely counterfeit.
The counterfeit Avastin was purchased from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions, according to FDA. QSP’s products are distributed by Volunteer Distribution in Gainesboro, Tenn.
FDA advised that any medical practices with products from Volunteer Distribution and QSP should stop using them and contact the agency. To report suspect products:
• Call FDA's Office of Criminal Investigations (OCI) at (800) 551-3989.
• Visit OCI's website.
Healthcare professionals are encouraged to report all serious adverse events to FDA’s MedWatch website