[2/5/2013] The Food and Drug Administration is committed to protecting the supply chain against counterfeit and unapproved medicines that enter the United States through fraudulent sources. As part of this vigilance, FDA is alerting health care professionals that an unapproved cancer medicine distributed by a U.S. company, Medical Device King (also known as Pharmalogical), is counterfeit.
FDA lab tests have confirmed that at least one batch of a counterfeit version of Roche’s Altuzan distributed in the United States contains no active ingredient.
Even if the identified product were not counterfeit, Altuzan (bevacizumab), an injectable cancer medicine, is not approved by FDA for sale in the United States. The only FDA-approved version of bevacizumab for sale in the United States is called Avastin, marketed by Genentech.
Medical practices that have obtained any medical products from Medical Device King, Pharmalogical, and Taranis Medical (another company associated with Pharmalogical) should stop using the products due to concern that the products may be unsafe or not effective. Health care professionals should contact FDA’s Office of Criminal Investigations (OCI) to arrange for the collection of these products.
Medical practices that purchase and administer unapproved medicines are putting patients at risk of exposure to medicines that may be counterfeit, contaminated, or improperly stored and transported. For most of these medicines, there are FDA-approved versions readily available in the United States. FDA cannot ensure the safety and efficacy of any product that has not undergone the rigorous scientific review that is part of FDA’s approval process. To protect patient health, health care professionals should use only FDA-approved medicines.
The product labeled as Altuzan (bevacizumab) 400 mg/16 mL may be counterfeit if it displays the following batch numbers and expiration dates:
|Batch No.||Exp. date|
(These batch numbers are in addition to those previously identified by FDA as suspect counterfeit products.1)
How Health Care Professionals Can Help Ensure Safety of their Patients
To minimize the chance of patients being exposed to medicines that may be counterfeit, contaminated, or improperly stored and transported, health care professionals should be cautious when ordering products from new or unknown suppliers.
1. Be wary if the price of a medicine sounds too good to be true. Deep discounts may be offered because the product is stolen, counterfeit, substandard, or unapproved.
2. Carefully inspect the product and packaging. Look for these signs, which may indicate that the product is not FDA-approved:
- The medicine has a different name than what was ordered.
- The packaging or label looks different from the product you usually receive.
- Portions, or all, of the labeling are not in English.
- The dosing recommendations are unfamiliar.
- The dosage form or route of administration is different (e.g., ampule instead of pre-filled syringe).
- The product does not display a National Drug Code (NDC) number.
4. If you receive multiple complaints about the same product, such as a new side effect or lack of therapeutic effect, these may signal a product quality issue. Report product quality issues and adverse events to FDA using the MedWatch system.
Health care professionals and patients should report adverse events related to the use of suspect medicines to FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online, by regular mail, by fax, or by phone. Health care professionals and consumers can either:
- Complete and submit the report online: www.fda.gov/MedWatch/report.htm, or
- 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.
FDA is asking the public to report suspect products obtained from Medical Device King, Pharmalogical, Taranis Medical, or other questionable sources:
- Call FDA’s Office of Criminal Investigations (OCI) at 800-551-3989, or
- Report to OCI at www.accessdata.fda.gov/scripts/email/oc/oci/contact.cfm, or
- Email - DrugSupplyChainIntegrity@fda.hhs.gov
FDA is committed to promoting and protecting the public health by ensuring that safe, effective, and high-quality products are available to the American public.
1 Links to previous FDA alerts:
- Another counterfeit cancer medicine found in the U.S. – Illegal practice puts patients at risk (FDA Archive)
- Counterfeit version of Avastin in U.S. Distribution (FDA Archive)