The FDA is alerting US medical practices of another counterfeit cancer drug originating from a foreign source.
According to FDA lab tests, an imitation version of Roche’s Altuzan 400 mg/16 mL (bevacizumab), a drug not approved by the FDA for use in the US, is actually in the country and contains no active ingredient.
The counterfeit Altuzan and other unapproved products were obtained through foreign sources, in particular from Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc (BDMI).
Any medical practice that has obtained unapproved products from these companies should discontinue their use and contact the FDA. Retain and securely store the products until further notice by the FDA.
Healthcare professionals should report adverse events related to the use of suspect injectable cancer medicines to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. Health care professionals can either:
- Complete and submit the report online
- Download the form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the preaddressed form, or submit by fax to 1-800-FDA-0178
Please report suspect counterfeit products and other suspect products obtained from Richards Pharma, Richards Services, Warwick Healthcare Solutions, BDMI, or other sources:
- Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989
- Visit OCI’s Web site
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Source: FDA.