For the first time in less than 6 months, FDA is warning consumers against purchasing or using three “copycat” eye drop products of Bausch + Lomb’s LUMIFY (brimonidine tartrate ophthalmic solution) 0.025% drops due to the potential risk for infection.
Let’s get right to it: which eye drops?
- South Moon
- Manufacturer: Shantou Cross-border Premium Products E-Commerce Co. Ltd. (according to the product label)
- Country of origin: Guangdong, China (Shantou District)
- REBRIGHT
- Manufacturer: Currently unclear (however, according to an offshore website, it is a compound Chinese company name, Haikoulinchangwangluokejiyouxiangongsi)
- Country of origin: Haikou City, China (Melian District)
- FiVFIVGO
- Manufacturer: Currently unclear (however, according to an offshore website for a different ophthalmic formulation, it is another compound Chinese company name, Shenzhenshijiuanwangluoyouxiangongsi)
- Country of origin: Shenzhen, China
Per the FDA, all three unapproved products are sold online and claim to treat ocular conditions such as glaucoma, cataracts, presbyopia, and ocular hypertension.
And what’s this risk for infection?
Following sample testing of the South Moon and REBRIGHT eye drops, the federal agency found the South Moon eye drops were contaminated with “Burkholderia cepacia complex, a group of bacteria that could result in an antibiotic-resistant infection,” the FDA reported.
To note, the agency was unable to obtain a sample of FiVFIVGO to test for the same bacteria.
Did REBRIGHT also show contamination?
As of the agency’s report on Jan. 31, 2024—no. Product testing for those drops was negative for contamination.
However, to err on the side of caution, the FDA is still advising consumers against using the product.
Talk about this product the drops are based on.
Consumers may mistake any of the three eye drops for B+L’s LUMIFY, which has been authorized for distribution by the FDA since 2017.
LUMIFY is marketed as the first and only over-the-counter (OTC) eye drop formulated with low-dose brimonidine tartrate to treat ocular redness due to minor eye irritations for adults and children aged 5+.
Per its clinical information, LUMIFY’s effects are intended to provide up to 8 hours of relief.
How are the copycats different from LUMIFY?
For starters (and perhaps, most importantly): The FDA’s testing of both REBRIGHT and South Moon eye drops found that “these copycat products lacked brimonidine tartrate, the active ingredient in Lumify.”
As a reminder: Samples of FiVFIVGO were unable to be obtained.
And what makes them similar to LUMIFY?
Aside from the products’ falses indication claims, their packaging is nearly identical to that of LUMIFY—right down to a fake “Bausch + Lomb” label.
Based on further investigation and information from the offshore website, a pictorial claims that the product included ingredients such as taurine, Vitamin B6, and aspartic acid in addition to the brimonidine tartrate.
Click here for a visual of these products.
Have any adverse events been reported?
As of Jan. 31, the “FDA has not received any adverse event reports that specifically name the South Moon, Rebright or FivFivGo products,” it stated.
The agency noted, however, that it has received reports associated with a potentially fake LUMIFY, “including product quality concerns, eye irritation, pain and infection.”
So what do we know about any of these manufacturers?
Not much… Shantou Cross-border Premium Products E-Commerce Co. Ltd., South Moon’s manufacturer, is reported to have been established in 2014 and based in Guangdong, China.
The business is labeled as a “trading company,” with its main markets being in Southeast Asia, South America, and the domestic market.
The North American market is noted as accounting for 10% of its business.
Has Bausch + Lomb addressed this situation yet?
They have!
In a statement to Glance, the company said that, "Consumers can be confident that authentic LUMIFY redness reliever eye drops are made with the highest standards of safety and efficacy."
Additionally, "We’re working closely with the FDA and our authorized retail partners to help protect individuals from copycat products."
Now what?
Now we wait for additional information to be released, particularly regarding the still-unknown manufacturers of the REBRIGHT and FiVFIVGO eye drops.
In the meantime, the FDA is advising patients and eye care providers to report any adverse events tied to the use of any of the three eye drops to its MedWatch Adverse Event Reporting program.
To file a report, click here.
And to think I thought we were done with these eye drop recalls...
Us too. If you’re feeling nostalgic (we kid), click here for a lookback at last year’s plethora of recalls and warnings.
Editor's note: This story was updated on Monday, Feb. 5, 2024, to include a statement from Bausch + Lomb.