April 04, 2012
SAFETY ALERT: Counterfeit Altuzan WarningThe FDA has confirmed that a counterfeit version of Roche's Altuzan 400mg/16mL (bevacizumab), an injectable cancer medication, found in the US contains no active ingredient. Even if the identified drugs were not counterfeit, Altuzan is not approved by FDA for use in the US; it is an approved drug in Turkey. The only FDA-approved version of Altuzan for use in the US is marketed as Avastin by Genentech (a member company of Roche).
Counterfeit Altuzan and other unapproved products were found to be obtained through foreign sources, in particular from Richards Pharma (Richards Services), Warwick Healthcare Solutions, or Ban Dune Marketing Inc (BDMI). Many of the products sold and distributed through this distributor have not been approved by the FDA. Packaging or vials found in the US that claim to be Roche's Altuzan with Lot# B6021 should be considered counterfeit. Any medical practice that has obtained unapproved products should retain and securely store all products until further notice by the FDA.
Avastin is indicated for metastatic colorectal carcinoma, in combination with 5-FU-based chemotherapy; first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer (NSCLC), in combination with carboplatin and paclitaxel; glioblastoma, as a single agent for patients with progressive disease following prior therapy; and metastatic renal cell carcinoma (mRCC) in combination with interferon alfa.
For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm298583.htm.