FDA Warning Announced Regarding Contamination of Copycat Eye Drops

The US Food and Drug Administration (FDA) cautioned eye drop consumers against the use or purchase of eye drops from South Moon, FivFivGo, or Rebright, which officials warn are copycat products which could lead to possible eye infection.¹

The imitation eye drops could be easily confused with Bausch + Lomb's Lumify brand eye drops, an FDA-approved product which is provided over-the-counter and designed for redness relief. The unapproved eye drop products, with claims of treatment for conditions such as glaucoma that require surgery or prescription drugs, should not be available for sale within the US.

The FDA’s January 31 announcement also included a comparison of the authentic Lumify product with the copycat ones, cautioning consumers to look out for the false labeling of "Bausch + Lomb." The image appears different from the real products.

Testing which had been conducted showed that there had been contamination in South Moon eye drops with Burkholderia cepacia complex, a bacteria group known to potentially lead to antibiotic-resistant infections. FDA officials did note that their Rebright assessments suggested no contamination but the agency did advise against its use by consumers.

The active ingredient brimonidine tartrate which is found in Lumify does not exist in both of the copycat eye drop products. Officials are investigating the origin of the imitation products, noting that South Moon was labeled as manufactured by Shantou Cross-border Premium Products E-Commerce Co. Ltd. in China.

There have not yet been adverse event reports received by the FDA that specifically concern these products, but questionable Lumify product reports related to quality and infections have been provided to the agency. The FDA announcement also urged those using eye drop products like these to buy such products only from state-licensed pharmacies and reputable retailers, in addition to maintaining caution of online sellers.

In the announcement, officials with the agency also advised consumers to consult their healthcare provider or to look for medical attention promptly if they do get an eye infection, adding that proper disposal of these products is strongly recommended.

This message from the FDA echoes notable recent news of eye drop-related safety reports from the first months of 2023, covered by the HCPLive editorial staff in the recent This Year in Medicine feature series.² A bacterial outbreak linked to artificial tears had resulted in upwards of 80 eye infection cases and at least 4 deaths, leading to recalls.

Following these reports, the FDA and Centers for Disease Control and Prevention (CDC) have urged caution related to unapproved ophthalmic products. The new announcement of copycat products represents a continuation of awareness-raising measures.¹

Healthcare professionals and consumers are encouraged to report adverse events or side effects related to the aforementioned copycat products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program, which they provide a link to in their announcement. They can do this either through fax at 1-800-FDA-0178 or online.

References

1. ^{FDA warns consumers of contaminated copycat eye drops. US Food and Drug Administration. January 31, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-contaminated-copycat-eye-drops. Date accessed: February 1, 2024.}
2. ^{C Iapoce. Keeping an Eye Out: Safety Recalls Impact Over-the-Counter Eye Drops. HCPLive. December 27, 2023. https://www.hcplive.com/view/safety-recalls-impact-over-the-counter-eye-drops. Date accessed: February 1, 2024.}