(Reuters) WASHINGTON – The U.S. Food and Drug Administration said on Friday that fraudulent versions of the wrinkle treatment Botox, which is made by Allergan Inc and also used to treat headaches, underarm sweating and overactive bladder, are being sold in the United States.
The FDA said in an alert posted on its website that the outer carton of the fraudulent Botox is counterfeit, and the vial inside is foreign and not approved for sale in the United Sates.
“FDA cannot confirm that the manufacture, quality, storage, and handling of these products follow U.S. standards,” the agency said.
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Allergan said that in addition to violating federal law, products that are illegally imported may either be counterfeit or the quality may have been compromised.
“Therefore, healthcare professionals purchasing products from a non-Allergan supplier are purchasing products that are fraudulently diverted and sold through unauthorized channels,” the company said in a statement.
Authentic Botox is stored and transported by Allergan according to rigorous specifications, the company said.
