The U.S. Food and Drug Administration (FDA) has issued a warning to consumers not to use or purchase South Moon, Rebright, or FivFivGo eye drops due to the potential health risks associated with them.
These products, considered copycats of Bausch + Lomb's Lumify brand eye drops, could potentially cause eye infection, according to an FDA advisory.
Bausch + Lomb's Lumify is an over-the-counter eye drop approved for redness relief. However, the FDA emphasized that South Moon, Rebright, and FivFivGo eye drops are unapproved drugs and should not be available for sale in the U.S.
What's particularly concerning is that these copycat products claim to treat eye conditions such as glaucoma, a serious disease that typically requires prescription drugs or surgery.
The FDA conducted testing on samples of South Moon and Rebright eye drops, both purchased online. The South Moon eye drops were found to be contaminated with Burkholderia cepacia complex, a group of bacteria known to cause antibiotic-resistant infection.
Although testing for Rebright showed no contamination, the FDA still advised consumers against using this product.
Further analysis revealed that both South Moon and Rebright lacked brimonidine tartrate, the active ingredient found in Bausch + Lomb's Lumify and a drug is administered to address open-angle glaucoma or elevated fluid pressure within the eye.
The origin of these potentially harmful products remains unclear. The South Moon eye drops are labeled as being manufactured by Shantou Cross-border Premium Products E-Commerce Co. Ltd. in China.
While the FDA has not received adverse event reports specifically naming South Moon, Rebright, or FivFivGo products, it received reports related to potentially fake Lumify products. These reports included concerns about product quality, eye irritation, pain, and infection.
To address this issue, the FDA recommended that consumers only buy eye products from reputable retailers, such as state-licensed pharmacies. Additionally, the agency urged caution when dealing with online retailers, emphasizing the importance of verifying product claims.
As a precautionary measure, the FDA advised patients exhibiting signs or symptoms of an eye infection to consult their healthcare provider or seek medical attention promptly.
Moreover, consumers who have purchased South Moon, Rebright, or FivFivGo eye drops are urged to properly discard these products to avoid any potential health risks.
The FDA encouraged both healthcare professionals and consumers to report any adverse events or side effects associated with these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
Reports can be submitted online via the MedWatch Online Voluntary Reporting Form or by downloading and faxing the form to 1-800-FDA-0178.
The FDA said it will continue to investigate the origin and distribution of these potentially hazardous copycat eye drops.
