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Alphagan FDA Alerts

The FDA Alerts below may be specifically about Alphagan or relate to a group or class of drugs which include Alphagan.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for Alphagan

FDA Warns Consumers of Contaminated Copycat Eye Drops

Jan 31, 2024 | Audience: Consumers

January 31, 2024 -- FDA is warning consumers not to purchase or use South Moon, Rebright or FivFivGo eye drops because of the potential risk of eye infection.

These are copycat eye drop products that consumers can easily mistake for Bausch + Lomb’s Lumify brand eye drops, an over-the-counter product approved for redness relief.

South Moon, Rebright and FivFivGo eye drops are unapproved drugs and should not be available for sale in the U.S. They claim to treat eye conditions such as glaucoma, which is treated with prescription drugs or surgery.

Patients who have signs or symptoms of an eye infection should talk to their health care provider or seek medical care immediately. FDA recommends consumers properly discard these products.

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 Rebright testing was negative for contamination, FDA recommends consumers not use this product.

FDA testing of the Rebright and South Moon eye drops also found that these copycat products lacked brimonidine tartrate, the active ingredient in Lumify. FDA was unable to obtain FivFivGo samples.

The origin of these products is currently unclear, and FDA continues to investigate. South Moon is labeled as made by Shantou Cross-border Premium Products E-Commerce Co. Ltd. in China.

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.

The agency recommends consumers only buy eye products from reputable retailers such as state-licensed pharmacies and beware of online retailers selling products with false claims.

Comparison of authentic Lumify with copycat products

The South Moon, Rebright and FivFivGo photos are examples of the images that appear on various websites. Some of these copycat products may be falsely labeled with “Bausch + Lomb” at the top of the packaging. The actual products may look different.

Copycat eye drops

 
 

Authentic Lumify eye drops

 


Health care professionals and consumers should report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Source: FDA