FDA Warns Doctors About Unapproved Drug Products, Including Botox, Purchased from Foreign Suppliers
Emphasizing risks to patient safety, Food and Drug Administration (FDA) has alerted more than 350 medical practices (PDF) across the country that they may have received unapproved medications, including unapproved versions of Botox®, from a foreign supplier. FDA sent a letter warning the practices that these medications may be counterfeit, contaminated, improperly stored and transported, ineffective, and/or unsafe. FDA requested 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. FDA stressed that many, if not all, of the products sold and distributed by these suppliers have not been approved by FDA, and that the safety and efficacy of the products cannot be confirmed. Further, in a statement about the warning letters, 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.