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- Posted February 1, 2024
FDA Warns of Dangerous Counterfeit Eyedrops
Certain copycat eyedrops may be contaminated and could give users an antibiotic-resistant eye infection, the U.S. Food and Drug Administration warned Wednesday.
The packaging for South Moon, Rebright and FivFivGo eyedrops mirrors the packaging for Bausch & Lomb's Lumify eyedrops, an over-the-counter product approved for red eye relief.
However, samples of the knockoff South Moon eyedrops were contaminated with Burkholderia cepacia complex, a strain of bacteria that could result in an antibiotic-resistant infection, the FDA said in a news release.
B. cepacia is a known cause of infections in hospitalized patients, and poses a particular risk to people with weakened immune systems or chronic lung diseases, according to the U.S. Centers for Disease Control and Prevention.
People with symptoms of an eye infection should talk with their doctor or seek medical care immediately, the FDA advised.
Rebright tested negative for contamination, but both Rebright and South Moon lacked the active ingredient in Lumify, brimonidine tartrate. No samples of FivFivGo drops could be obtained for testing and analysis.
The FDA recommends consumers not use any of the products, since they are unapproved and should not be for sale in the United States. Consumers who've bought these products should throw them out.
The origin of the products is currently unclear, the FDA added. South Moon's label says it is made by Shantou Cross-border Premium Products E-Commerce Co. Ltd. in China.
The knockoffs claim to treat eye conditions like glaucoma, which can only be treated with prescription medicines or surgery, the agency added.
The FDA hasn't received any reports that specifically name South Moon, Rebright or FivFivGo as a source of infection.
However, the agency has received reports related to potentially fake Lumify, including product quality concerns, eye irritation, pain and infection.
Consumers should only buy eye products from reputable retailers like state-licensed pharmacies, the FDA recommends. They should be wary of online retailers selling products with false claims.
More information
The U.S. Centers for Disease Control and Prevention has more about Burkholderia cepacia.
SOURCE: U.S. Food and Drug Administration, news release, Jan. 31, 2024
What This Means for You
People who've purchased knockoff eye drops should throw them away, and report any ill effects to the FDA.
