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Enforcement: Counterfeit versions of Botox® in the United States, found in doctor’s offices and medical clinics

Enforcement: Counterfeit versions of Botox® in the United States, found in doctor’s offices and medical clinics

April 16th 2015 - www.securingindustry.com
www.fda.gov

Counterfeit Botox versions were sold in the US by an unlicensed supplier not allowed to ship or distribute pharmaceutical product. These products, which come in the hands of US health professionals and medical clinics, are considered as dangerous to health and therefore, should not be used. In fact, the Food and Drug Administration (US Health Authority) is not able to confirm that the suspects’ products follow the US standards of manufacture, quality, storage and handling. The FDA says that counterfeit products can be identified by the lot number (which, in this case, is absent from the bottle), inscriptions on the packaging (date of manufacture MFG and date of expiry EXP not present in this case) and the name of the active ingredient (the term "Botulium Toxin Type A" was false, the real name is "onabotulinumtoxinA"). Health professionals are encouraged to check with the manufacturer of the "real" Botox (Botox approved by the FDA) that the distributor is authorized to distribute the Botox. In addition, the FDA asks patients to report suspected products, by calling the Office of Criminal Investigations (OIC), by making a report to OIC or by email to the FDA.