FDA warns consumers of contaminated copycat eye drops

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The FDA has issued a warning to consumers not to purchase or use South Moon, Rebright, or FivFivGo eye drops because of the potential risk of eye infection.

According to an FDA news release,¹ the drops in question are copycat eye drop products that consumers can easily mistake for Bausch + Lomb’s Lumify brand eye drops, an over-the-counter product approved for redness relief.

The FDA noted in its news release that the South Moon, Rebright and FivFivGo eye drops are unapproved drugs and should not be available for sale in the US. The makers claim the drops can treat several eye conditions, including glaucoma, which is treated with prescription drugs or surgery.

Moreover, the FDA noted that patients who have the signs or symptoms of an eye infection should talk to their healthcare provider or seek medical care immediately. FDA recommends consumers should get rid of the products in an appropriate manner.²

According to the news release, the FDA tested samples of South Moon and Rebright eye drops, purchased online. The South Moon eye drops were contaminated with Burkholderia cepaciacomplex, a group of bacteria that could result in an antibiotic-resistant infection. While Rebright testing was negative for contamination, the FDA recommends consumers not use this product.

Additional tests of the drops by the FDA also revealed the copycat products lacked brimonidine tartrate, the active ingredient in Lumify. FDA was unable to obtain FivFivGo samples.

The origin of these products is currently unclear, and FDA continues to investigate. South Moon is labeled as made by Shantou Cross-border Premium Products E-Commerce Co Ltd in China.¹

According to the news release, the FDA has yet to receive any adverse event reports that specifically name the South Moon, Rebright, or FivFivGo products. However, the agency has received reports related to possibly fake Lumify, including product quality concerns, eye irritation, pain and infection.¹

The FDA noted that consumers should only purchase products from reputable retailers such as state-licensed pharmacies and beware of online retailers selling products with false claims.

References:

1. Research C for DE and. FDA warns consumers of contaminated copycat eye drops. FDA. Published online January 31, 2024. Accessed February 1, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-contaminated-copycat-eye-drops

2. Center for Drug Evaluation and Research. Disposal of Unused Medicines: What You Should Know. U.S. Food and Drug Administration. Published 2019. https://www.fda.gov/drugs/safe-disposal-medicines/disposal-unused-medicines-what-you-should-know