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U.S. Department of Health and Human Services

Drugs

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Letters to Doctors About Purchasing Unapproved Injectable Cancer Medications

 

FDA received information that the medical practices listed below purchased medications from a foreign supplier, Quality Specialty Products (QSP) (also known as Montana Health Care Solutions). Volunteer Distribution of Gainesboro, Tennessee is a distributor of QSP products in the U.S. Many of the products have not been approved by the FDA. FDA has learned that one of the products from these suppliers is a counterfeit version of Roche’s Avastin 400 mg/16 mL. The Agency is very concerned that these products may cause harm to patients because they are unsafe or ineffective. To minimize the chance of patients receiving a counterfeit or unsafe or ineffective product, FDA is requesting that the medical practices stop administering products purchased from QSP and received from Volunteer Distribution or any other unapproved foreign source. These products may be from unknown sources, have unknown ingredients, and may not have been manufactured, transported or stored under proper conditions required by U.S. law, regulations, and standards.

 

 

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