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.
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.
Botox is a sterile, purified version of the same toxin that causes botulism, which can cause potentially deadly swallowing and breathing difficulties, and when injected, acts to temporarily smooth certain frown lines. It generated sales in 2012 of $1.77 billion, of which roughly half came from cosmetic use.
In 2004, four people were hospitalized with poisoning after being injected with unapproved botulinum toxin, which a doctor had passed off as Botox.
The case prompted a wide scale investigation of more than 200 clinics throughout the United States and dozens of convictions of people who injected patients with unapproved, cheaper substitutes for Botox.
The FDA's alert comes as lawmakers are seeking to create a national set of standards for tracking prescription drugs through the distribution chain to help prevent counterfeit or contaminated products from reaching the public.