Counterfeit Botox Shows Up in the U.S.

April 23, 2015

The FDA is warning that a counterfeit version of Allergan’s Botox might be in doctors’ offices and medical clinics across the nation.

Like Allergan’s Botox, the counterfeit product is available in vials with purple stoppers and labeled as containing 100 units. However, FDA-approved Botox displays the active ingredient as “OnabotulinumtoxinA” on its vial and outer carton, while the fake version displays the active ingredient as “Botulinum Toxin Type A,” the agency says.

The counterfeit product is also missing the lot number on the vial, and the outer carton doesn’t have any entries next to the LOT: MFG: EXP:, the FDA adds.

FDA spokesman Christopher Kelly says investigators are trying to determine the identity and location of the unlicensed supplier.

In the meantime, Allergan’s Botox should be considered safe and effective for its intended uses, the FDA says. To prevent counterfeiting, the vials have a hologram image that says “Allergan.” A U.S. license number on the side of the box indicates that the product was packaged in the U.S.

The agency is advising health practitioners to check with Allergan or the FDA’s website to determine if they purchased Botox from an authorized distributor. Suspect products should be reported to the FDA.

Allergan spokeswoman Ember Garrett says the company working with the FDA.

To verify wholesale drug distributor licenses with the FDA, go to www.fdanews.com/04-20-15-Distributors.pdf.  — Kellen Owings