further details: FDA MedWatch - Altuzan (bevacizumab): Counterfeit Product - Contains no Active Ingredient

Subject: Apr 3rd FDA MedWatch - Altuzan (bevacizumab): Counterfeit Product - Contains no Active Ingredient

Altuzan (bevacizumab): Counterfeit Product - Contains no Active Ingredient

ISSUE: FDA lab tests have confirmed that a counterfeit version of Roche’s Altuzan 400mg/16ml (bevacizumab),an injectable cancer medication, found in the U.S. contains no active ingredient. Even if the identified drugs were not counterfeit, Altuzan is not approved by FDA for use in the United States (it is an approved drug in Turkey).

BACKGROUND: Medical practices obtained the counterfeit Altuzan and other unapproved products through foreign sources, in particular from Richards Pharma, also known as Richards Services, Warwick Healthcare Solutions, or Ban Dune Marketing Inc (BDMI).  Many, if not all, of the products sold and distributed through this distributor have not been approved by the FDA. Pictures of the counterfeit version of Altuzan are shown in the FDA statement. Packaging or vials found in the U.S. that claim to be Roche’s Altuzan with lot number B6021 should be considered counterfeit.
RECOMMENDATION: 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

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the FDA statement, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm298583.htm

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You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

FDA identifies more bogus cancer drugs (Avastin - labeled as Altuzan) in U.S | Reuters

FDA identifies more bogus cancer drugs in U.S | Reuters

Tue Apr 3, 2012 8:31pm EDT
 

(Reuters) - The U.S. Food and Drug Administration on Tuesday said it has identified a new batch of counterfeit cancer drugs distributed in the United States and is urging doctors to avoid using the products, which contain no active ingredient.
The fake versions of Swiss drugmaker Roche's widely used cancer drug Avastin are labeled as Altuzan, which is the brand name that Avastin is sold under in Turkey, and do not contain the drug's active ingredient, bevacizumab.

FDA commissioner talks counterfeit drugs (and drug shortages) - CNN.com

FDA commissioner talks counterfeit drugs - CNN.com

Counterfeit drugs: a growing global threat : The Lancet

"The fight against counterfeit drugs must be strengthened without further delay. It needs consensus among all countries and interested parties, and requires wise and bold leadership from WHO. An indispensable goal of the campaign is ensuring the availability of genuine and affordable essential medicines in developing countries."

Denmark's CareMed says shipped fake Avastin unwittingly | Reuters (last year?)

Fri Feb 17, 2012 3:18pm EST (Reuters) - "Danish drug distributor CareMed said it was an unwitting link in the journey of fake cancer medicine Avastin from Switzerland to Britain, in the latest twist in a saga that began when the counterfeit drugs surfaced in the United States last year.
The fake version of the multi-billion dollar Roche drug had been traced back as far as Egypt before entering a complex supply chain that ended in California......
A Swissmedic spokeswoman said it looked as if the distributor had no knowledge that the drugs were fake, a view echoed by Britain's Medicines and Healthcare Products Regulatory Agency.
"There is no suggestion (CareMed and Hadicon) knew it was counterfeit," a MHRA spokesman said......."

update with specific locationst: Avastin (bevacizumab): Counterfeit Product - FDA Issues Letters to 19 Medical Practices California, Illinois, Texas

 The U.S. Food and Drug Administration is warning healthcare professionals and patients that a counterfeit version of Avastin (bevacizumab) 400mg/16mL was purchased and may have been used by 19 medical practices — 16 in California , 1 in Illinois, and 2 in Texas

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From: FDA MedWatch
Date: 02/14/2012
Subject: FDA MedWatch - Avastin (bevacizumab): Counterfeit Product - FDA Issues Letters to 19 Medical Practices

Avastin (bevacizumab): Counterfeit Product - FDA Issues Letters to 19 Medical Practices

AUDIENCE: Oncology, Pharmacy, Patient

ISSUE: The FDA is warning healthcare professionals and patients about a counterfeit version of Avastin 400mg/16mL, which may have been purchased and used by some medical practices in the United States. The counterfeit version is labeled as Avastin, manufactured by Roche and does not contain the medicine's active ingredient, bevacizumab, which my have resulted in patients not receiving needed therapy. 19 medical practices in the United States purchased unapproved cancer medicines from Quality Specialty Products (QSP), a foreign supplier that may also be known as Montana Health Care Solutions. Volunteer Distribution in Gainesboro, Tennessee is a distributor of QSP’s products. 

BACKGROUND: Avastin is an injectable medicine used to treat cancer and is administered to patients in clinics, hospitals, and doctors' offices. Roche is the company that manufactures Avastin approved for marketing outside of the United States. Roche conducted laboratory tests that confirmed the counterfeit version of Avastin. Packages or vials may be counterfeit if they:

• are labeled with Roche as the manufacturer
• display batch numbers that start with B6010, B6011 or B86017  

The only FDA-approved version of Avastin for use in the United States is marketed by Genentech (a member company of Roche). The FDA-approved version does not include the Roche logo on the packaging or vials. FDA approved versions of these medicines are available in adequate supply to meet demand.

RECOMMENDATION: Medical practices that have obtained products from Volunteer Distribution and QSP should stop using them and contact the FDA. These products should be retained and securely stored. To report suspect counterfeit products and other suspect products obtained from Volunteer Distribution or QSP/Montana Health Care Solutions:

• Call FDA's Office of Criminal Investigations (OCI) at 800-551-3989,
• Visit OCI's Web site (www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm), or
• Email - DrugSupplyChainIntegrity@fda.hhs.gov

Healthcare professionals and patients are encouraged to report adverse events related to the use of suspect injectable cancer medications to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the FDA Counterfeit Statement, letters to medical practices, and the company Press Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm291968.htm

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You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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Genentech: Newsroom: Press Statement: GENENTECH STATEMENT ON COUNTERFEIT DRUG LABELED AS AVASTIN® (BEVACIZUMAB) IN THE UNITED STATES

GENENTECH STATEMENT ON COUNTERFEIT DRUG LABELED AS AVASTIN® (BEVACIZUMAB) IN THE UNITED STATES
SOUTH SAN FRANCISCO, Calif. -- February 14, 2012 -- Roche and Genentech have been informed that a counterfeit product, labeled as Avastin (bevacizumab), has been distributed in the United States.
The counterfeit product is not safe or effective and should not be used. Chemical analyses of the counterfeit vials tested to date have confirmed the product does not contain the active ingredients for Avastin.
Patient safety is Roche and Genentech's primary concern. We are working with the U.S. Food and Drug Administration (FDA) and law enforcement to aid their evaluations, determine the source of the counterfeit drug, and prevent its further distribution...."