Counterfeit Altuzan Bevacizumab Found Without Active Ingredient

The general public is being warned by the FDA of the presence of a counterfeit version of Altuzan Bevacizumab by Roche; it was found to be without any active ingredient present.

Background of Altuzan (bevacizumab)

Altuzan (Bevacizumab) is a IV cancer drug for injection and it has a presence in the United States, although it is not FDA-approved but however has been approved in Turkey.

FDA Alert on Altuzan (bevacizumab)

Altuzan has been established as not having any FDA approval and further analysis on the drug by the FDA established the absence of any active ingredient and this is with reference to: Altuzan 400mg/16ml.

There is a number of medical healthcare facilities that have acquired counterfeit versions of Altuzan, in addition to other various unapproved drugs from foreign distributors including:

• Richards Services or Richards Pharma
• BDMI – Ban Dune Marketing Inc.
• Warwick Healthcare Solutions

Most or all of the medical products distributed by the aforementioned distributors have been identified as counterfeit.

For US consumers or users who have purchased Altuzan (bevacizumab), the counterfeit version of Altuzan comes with the product lot no. B6021.

FDA Recommendation on Altuzan (bevacizumab)

• “Any medical practice that has obtained unapproved products, in particular from Richards Pharma, Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc (BDMI), should stop using them and contact the FDA.
• The products should be retained and securely stored until further notice by the FDA.
• FDA is asking the public to report suspect counterfeit products and other suspect products obtained from Richards Pharma, Richards Services, Warwick Healthcare Solutions, Ban Dune Marketing Inc (BDMI), or other sources:
  • Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989, or
  • Visit OCI’s Web site – (www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm), or
  • Email – DrugSupplyChainIntegrity@fda.hhs.gov “

Contacting the FDA to report cases with Altuzan (bevacizumab)

Any adverse side effects or incidences relating to Altuzan (bevacizumab) or its counterfeit version should immediately be reported to the FDA in the event that a patient or medical professional experiences this.

This should be done by contacting or informing the FDA’s MedWatch Safety Information & Adverse Event Reporting Program through any of the following ways:

• Filling and submitting an online report at: http://www.fda.gov/MedWatch/report.htm
• Download the case reporting form at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
• Dialing 1-800-332-1088 and requesting to get a report form, filling it and returning it to the address indicated on the form
• Faxing the filled-up form to the fax number: 1-800-FDA-0178

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