The U.S. Food and Drug Administration (FDA) has alerted more than 350 medical practices that they may have received unapproved medications, including unapproved versions of Botox, from a foreign supplier. These medications may be counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe. Medical practices that purchase and administer illegal and unapproved medications from foreign sources are placing patients at risk and potentially depriving them of proper treatment.
To minimize the chance of patients receiving an unapproved, counterfeit, unsafe, or ineffective medication, FDA requests that medical practices stop administering the unapproved versions of Botox and any other products they have received from foreign suppliers owned and operated by Canada Drugs and known under the following names: Quality Specialty Products (QSP), A+ Health Supplies, QP Medical, Bridgewater Medical, or Clinical Care. Many, if not all, of the products sold and distributed by these suppliers have not been approved by FDA. Therefore, FDA cannot confirm that the manufacture and handling of these products follow U.S. regulations or that these medications are safe and effective for their intended uses.
Medications not approved by FDA may also lack the necessary and required labels that ensure their appropriate and safe use. For example, unapproved botulinum toxin products may not contain the boxed warning or Medication Guide required in FDA-approved botulinum products. As a result, health care practitioners and patients may not be fully informed of the potential serious risk of harm or death from the use of these products.
The text of the letter FDA sent to the physicians or medical practices on November 30, 2012 is below, along with a list of the doctors and clinics to which the letter was sent.
FDA urges the health care community to examine its purchasing practices to make sure that products are purchased directly from the manufacturer or from state-licensed wholesale drug distributors in the United States. Health care professionals, pharmacies, and wholesalers/distributors are valuable partners in efforts to protect consumers from the risks of unsafe or ineffective products that may be stolen, counterfeit, contaminated, or improperly stored and transported. The receipt of suspicious or unsolicited offers from unknown suppliers should be questioned, and extra caution should be taken when considering them.
Report any suspected criminal activity to FDA's Office of Criminal Investigations (OCI) by calling 1-800-551-3989 or visiting the OCI Web Site.
To verify that a wholesale drug distributor is licensed in the state(s) where it is conducting business, use the link or contact information provided for each respective state.
http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/ucm330610.htm
