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FDA Issues Warning of Contaminated Copycat Eyedrops

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The agency issued the warning against three brands of unapproved eyedrops designed to look like an approved brand.

Be careful what you put in your eye.

FDA

FDA

FDA has issued a warning for consumers to be on the lookout for copycat eyedrops.1 Specifically, consumers should be wary of purchasing eye drops that are designed to look like Bausch + Lomb’s Lumify brand. While Lumify is approved for redness relief, the noted brands are not approved by FDA.

The brands are as follows: South Moon, Rebright, and FivFivGo.

The agency’s warning was posted with an image showing how the three brands packaging and branding is designed to look exactly like Lumify. While each brand is clearly marked with its own name, the box’s all use the same color scheme and each feature the same drawing of a women’s eye with a purple tint to it. The drug information is also laid out in the same exact pattern on each box.

The medication itself is also packaged in a similar container to Lumify, with a short white plastic bottle and a purple top. FDA points out, however, that these images are how the medications are marketed on websites and that the actual packaging and containers may appear different in person.

According to FDA, the risk of using these copycat products goes beyond just being duped as a consumer. Two brands, South Moon and Rebright, were tested by the agency. The South Moon sample was found to be contaminated with Burkholderia cepacia, which is a bacteria that can cause an anti-biotic resistant infection.

The Rebright sample did not show any signs of contamination. FDA was unable to obtain a sample of FivFivGo. Regardless, the agency is still warning against the use of each brand. This is partially due to reports that agency has received claiming that fake Lumify medications have caused eye irritation, pain, and infection.

Neither Rebright or South Moon were found to contain the active ingredient of Lumify, brimonidine tartrate.

In a statement obtained by CNN, a spokesperson for Bausch + Lamb said, “Consumers can be confident that authentic Lumify redness reliever eye drops are made with the highest standards of safety and efficacy. We’re working closely with the FDA and our authorized retail partners to help protect individuals from copycat products.”2

This is just the latest example of fake medication that can potentially cause harm appearing on the market.

In late January, Pharmaceutical Executive reported that three US residents potentially ingested a counterfeit version of Ozempic, a popular weight-loss drug.3 The three victims experienced hypoglycemia, which is believed to be a result of the counterfeit medication. Ozempic is a highly popular medication and many consumers have had trouble getting their hands on it. This created a highly advantageous situation for counterfeit drug makers.

FDA urges consumers to avoid counterfeit medications and to only purchase medications from reputable sources, such as state-licensed pharmacies.

Sources

  1. FDA warns consumers of contaminated copycat eye drops. FDA. January 31, 2024. Accessed February 2, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-contaminated-copycat-eye-drops
  2. Cheng, Mira. FDA warns of copycat eye drops that may be contaminated and ineffective. January 31, 2024. Accessed February 2, 2024. https://www.cnn.com/2024/01/31/health/fda-eye-drop-copycat-warning-wellness/index.html
  3. Tracy, Donald. Report: Three US Residents Suffering from Hypoglycemia Used Suspected Counterfeit Ozempic. January 26, 2024. Accessed February 2, 2024. https://www.pharmexec.com/view/report-three-us-residents-suffering-from-hypoglycemia-used-suspected-counterfeit-ozempic
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