FDA Warning: South Moon, Rebright, FivFivGo copycat eye drops contaminated

FDA Public Warning 1/31/24

The FDA has identified 3 Lumify copycat drops sold on Walmart.com and other ecommerce sites. The agency is warning consumers not to use South Moon, Rebright, or FivFivGo eye drops.

Key takeaways:

  • South Moon, Rebright, and FivFivGo eye drops (pictured left) are advertised to look like Bausch and Lomb’s Lumify Redness Relieving Drops. FDA testing revealed South Moon and Rebright did not contain the active ingredient in Lumify, brimonidine tartrate.

  • The FDA tested two products and found bacterial contamination in one:

    “The agency tested samples of South Moon and Rebright eye drops, purchased online. The South Moon eye drops were contaminated with Burkholderia cepacia complex, a group of bacteria that could result in an antibiotic-resistant infection.”

  • While online product photos depict these copycat eye drops in Lumify’s uniquely shaped bottle, when DEF received copycat South Moon and Rebright drops in early 2023, the drops were packaged in standard multi-dose bottles (pictured right).

  • The Dry Eye Foundation has questioned whether these eye drops contain a suitable and effective preservative.

  • Product labeling includes bogus indications (e.g. relieving “symptoms of” glaucoma, cataracts, ocular hypertension).

  • The FDA does not know the origin of these eye drops. South Moon is labeled as made in China.

  • None of the drops in question are registered with the FDA.

  • Other Lumify copycats have been linked to adverse events.

    “FDA has not received 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.”

Dry Eye Foundation reported copycat eye drops to FDA

The Dry Eye Foundation purchased South Moon and Rebright eye drops from Walmart.com and other online retailers in March and April of 2023 as part of its Eye Drop Safety internet surveillance program, and immediately placed South Moon, Rebright, and FivFivGo were on red alert status on its Eye Drop Safety Alerts Page. Subsequently, DEF reported these drops on the FDA’s online reporting form for unlawful medical product sales on the internet. In September 2023, DEF included photos of South Moon eye drops in a presentation of its internet surveillance to CDER PASE.

Past DEF Press Releases

4/14/23: Dry Eye Foundation Warns about Alarming Surge of Unsafe Eye Drops

5/4/23: Dry Eye Foundation Calls on Amazon and Walmart to Address Rampant Sales of Potentially Unsafe Eye Drops

6/22/23: Dry Eye Foundation Notifies Authorities of over 200 Potentially Unsafe Eye Drops

Walmart recall notification to consumers

On 1/31/24, DEF received a recall notification from Walmart.com regarding its past purchase of these drops.

 
 

Unsafe copycats still being sold on multiple websites

As of 2/1/24, numerous ecommerce stores are continuing to sell South Moon, Rebright, and FivFivGo eye drops. (Example 1, Example 2, Example 3, Example 4)

As of 2/1/24, Walmart.com lists a variety of South Moon-branded OTC drugs, including nasal sprays, hemorrhoid cream, medicated patches, and creams for lipoma removal and varicose veins.

A sampling of products are sold and shipped by

The Dry Eye Foundation urges consumers to report unlawful sales of medical products on the internet to the FDA.

About Eye Drop Safety

Eye Drop Safety is a patient safety initiative of the Dry Eye Foundation.

The Dry Eye Foundation maintains a database of OTC eye drops at alerts.eyedropsafety.org, including presumed safe eye drops and eye drops that are being sold without FDA registration, eye drops mentioned in FDA warning letters or public safety notifications, and eye drops being sold with questionable or unallowed ingredients.

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