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  5. Historical Information: FDA Issues Letters to Doctors Who May Have Purchased Counterfeit or Unapproved Prescription Drugs, 2012-2014
  1. Drug Supply Chain Integrity

Historical Information: FDA Issues Letters to Doctors Who May Have Purchased Counterfeit or Unapproved Prescription Drugs, 2012-2014

Fraudulent Versions of Botox Sold by Online Botox Pharmacy, Onlinebotox.com, and Onlinebotox

On July 11, 2013, FDA sent approximately 250 letters to medical practices that purchased medications from “Online Botox Pharmacy,” “Onlinebotox.com,” and “Onlinebotox,” that sold fraudulent versions of Botox. The medication’s outer carton was counterfeit, while the vial inside was labeled as a foreign version of Botox not approved by the FDA for sale in the United States.

Counterfeit Altuzan distributed by a U.S. company Pharmalogical, Inc., d/b/a Medical Device King

On May 13, 2013, FDA sent more than 1,000 letters to medical practices that may have received prescription drugs from Pharmalogical, Inc., d/b/a Medical Device King that were unapproved or counterfeit. FDA lab tests confirmed that this company distributed a counterfeit version of Altuzan that had no active ingredient.

Criminal Cases

Unapproved Botox Distributed by Quality Specialty Products (QSP), A+ Health Supplies, QP Medical, Bridgewater Medical, or Clinical Care

On November 30, 2012, FDA issued more than 300 letters to medical practices that purchased medications from a foreign supplier that distributed unapproved versions of Botox. These products may not contain the boxed warning or Medication Guide as required in FDA-approved products. Therefore, health care professionals and patients may not be fully informed of the potential serious risk of harm or death from the use of these products.

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Unapproved Prolia and Aclasta Sold by Distributors Owned and Operated by Canada Drugs

On September 10, 2012, FDA issued about 25 letters to medical practices that purchased multiple medications from at least one of several foreign distributors owned and operated by Canada Drugs – Montana Health Care Solutions, Quality Special Products (QSP), A+ Health Supplies, QP Medical, Bridgewater Medical, Infusion Options, UK Pharmacy Services, or Clinical Care. Most, if not all, of the products were unapproved, including Prolia and Aclasta.

Criminal Cases

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Unapproved Altuzan Distributed or Sold Richards Pharma, Quality Special Products, Volunteer Distribution, Clinical Care, and Bridgewater Medical

On June 28, 2012, FDA issued 60 additional letters to medical practices that purchased multiple medications from Clinical Care, QSP, Montana Healthcare Solutions, or Bridgewater Medical. These foreign distributors distributed counterfeit versions of Avastin and Altuzan. FDA lab tests confirmed a counterfeit version of Altuzan had no active ingredient.

On April 23, 2012, FDA issued 8 letters to medical practices that may have purchased counterfeit versions of Altuzan from Quality Special Products (QSP), also known as Montana Healthcare Solutions. FDA lab tests confirmed a counterfeit version of Altuzan had no active ingredient.

On April 5, 2012, FDA issued 60 letters to medical practices that purchased medication from the source of the counterfeit version of Altuzan, Richards Pharma (also known as Richards Services, Warwick Health Solutions, or Ban Dune Marketing Inc.). FDA lab tests confirmed a counterfeit version of Altuzan had no active ingredient.

Criminal Cases

Counterfeit Avastin Sold by Quality Special Products (QSP), also known as Montana Health Care Solutions

On February 10, 2012, FDA issued informational letters to medical practices that purchased medication from Quality Special Products (QSP), also known as Montana Health Care Solutions. QSP’s products were distributed through Volunteer Distribution based in Gainesboro, Tennessee. Many of the products sold and distributed by these suppliers were not approved by the FDA. One of the products was a counterfeit version of Avastin.

Criminal Cases

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