FDA Issues Warning on Contaminated Copycat Eye Drops

FDA Issues Warning on Contaminated Copycat Eye Drops

February 02, 2024

The U.S. Food and Drug Administration (FDA) is warning consumers against the purchase and use of South Moon, Rebright, or FivFivGo eye drops due to the potential risk of eye infection. These products, identified as copycats, pose a danger as consumers might easily mistake them for Bausch + Lomb's Lumify, an over-the-counter eye drop approved for redness relief.

South Moon, Rebright, and FivFivGo eye drops are considered unapproved drugs and should not be available for sale in the United States. Despite claiming to treat eye conditions such as glaucoma, these products are not authorized for use and lack the proper approvals required for medical products.

The FDA, after testing samples of South Moon and Rebright eye drops purchased online, found that South Moon eye drops were contaminated with Burkholderia cepacia complex, a group of bacteria capable of causing antibiotic-resistant infections. While Rebright testing yielded negative results for contamination, the FDA advises consumers against using this product.

Further analysis revealed that these copycat eye drops lack brimonidine tartrate, the active ingredient found in Lumify. The FDA was unable to obtain samples of FivFivGo for testing. The origin of these products remains unclear, and the FDA is actively investigating. South Moon is labeled as manufactured by Shantou Cross-border Premium Products E-Commerce Co. Ltd. in China.

Although the FDA has not received adverse event reports specifically linked to South Moon, Rebright, or FivFivGo, reports related to potentially fake Lumify, including concerns about product quality, eye irritation, pain, and infection, have been received.

Consumers are strongly advised to consult healthcare providers if they exhibit signs or symptoms of an eye infection and to properly discard these copycat products. The FDA recommends purchasing eye products only from reputable retailers, such as state-licensed pharmacies, and urges caution when dealing with online retailers selling products with false claims.

To assist consumers in identifying authentic products, the FDA has provided a visual comparison of genuine Lumify packaging with images of the South Moon, Rebright, and FivFivGo products found on various websites. Some copycat products may be falsely labeled with "Bausch + Lomb" at the top of the packaging, potentially misleading consumers. The FDA underscores the importance of vigilance and encourages the public to report any adverse events or concerns related to these products.

Copycat eye drops

Copycat Eye Drop

Authentic Lumify eye drops

Authentic Lumify eye drops

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