Today, the FDA is warning consumers of potentially contaminated copycat eye drops that are unapproved new drugs that “copy the Bausch + Lomb’s Lumify brand eye drops, an over-the-counter product approved for redness relief.”

While the FDA notes that it has not received any specific reports of adverse events with the three products named below, the FDA warning (here) states that “the agency has received reports related to possibly fake Lumify, including product quality concerns, eye irritation, pain and infection”; the warning also provides label copy of the copycat products (reproduced below) and notes that South Moon, Rebright, and FivFivGo eye drops are the subject of the warning.  The Agency tested samples of South Moon and Rebright eye drops, purchased online, and found that the South Moon product was contaminated with Burkholderia cepacia complex; it also found that both of the products failed to contain brimonidine tartrate, the active ingredient in Lumify.  The FDA indicated that it was unable to obtain samples of the FivFivGo product.  The labeling from each of the three products (see below) appears to be a copycat of the Lumify label.

The FDA continues to investigate the origin of these products, although it believes that at least one of them comes from China.  The number of fake and counterfeit products appearing in the U.S. marketplace has the Agency in a continuous game of whack-a-mole.  Early notification of these types of fake and potentially dangerous products is part of the early warning system for consumers to be on guard and aware that these fake products exist and to steer clear of them as the FDA works to take definitive regulatory and enforcement action.