Dec 19, 2012 -- 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, the 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,
Bridgewater Medical, or
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 FDA is warning that counterfeit Botox was found in the United States and may have been sold to doctors' offices and medical clinics nationwide.
Medications purchased from foreign or unlicensed sources may be misbranded, adulterated or counterfeit.
The counterfeit product is missing the lot number, does not have any entries next to the LOT: MFG: EXP, and lists the active ingredient as "Botulinum Toxin Type A" instead of "OnabotulinumtoxinA"
The counterfeit products are considered unsafe and should not be used. FDA cannot confirm that the manufacture, quality, storage, and handling of these suspect products follow U.S. standards.
FDA warns that botulinum toxin for research purposes is being sold as counterfeit Botox for human use.
The vials were clearly labeled, "For Research Purposes
Only, Not For Human Use"
This counterfeit product is labeled, "For Research Purposes Only, Not For Human Use"
Source: US FDA
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.