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FDA Warns Consumers: Certain Eye Drops Pose Risk of Infection, Urges Immediate Discontinuation

In a recent development, the Food and Drug Administration (FDA) has issued a stern warning to consumers, urging them not to purchase or use specific over-the-counter eye drops from several major brands due to the potential risk of eye infections.

The affected products, marketed under well-known brands such as CVS Health, Leader, Rugby, Rite Aid, Target Up & Up, Velocity Pharma, and Equate (Walmart), may pose a serious threat to eye health.

The FDA’s advisory, updated on [10/27/2023], reveals that a total of 26 over-the-counter eye drop products have been flagged for potential contamination. The agency has identified brands like CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up & Up, and Velocity Pharma in the list. These products, intended to be sterile, carry a heightened risk of harm to users due to the direct application of drugs to the eyes, bypassing some of the body’s natural defenses.

The FDA’s concerns stem from findings of insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas. The agency recommended the manufacturers recall all lots on [10/25/2023], emphasizing the importance of proper product disposal.

As a precautionary measure, CVS, Rite Aid, and Target have already started removing the affected products from their store shelves and websites. However, products branded as Leader, Rugby, and Velocity may still be available for purchase in stores and online, posing a potential risk to consumers.

Varied Formulations Affected: Check FDA’s Updated List

The affected eye drops span a range of formulations and purposes, including lubricant eye drops, dry eye relief, and multi-action relief drops. The FDA is actively updating the list of affected products and has included national drug codes (NDCs) to help consumers identify the specific items that pose a risk.

While the FDA has not received any adverse event reports of eye infections associated with these products as of now, it strongly encourages health care professionals and patients to report any adverse events or quality problems through the FDA’s MedWatch Adverse Event Reporting program.

Consumers are urged to check the FDA’s regularly updated list and verify the national drug codes (NDCs) of eye drops they have purchased. If you have any of the affected products, it is crucial to discontinue use immediately and consult with a healthcare provider if you experience any signs or symptoms of an eye infection.

In conclusion, the FDA’s warning serves as a crucial reminder of the importance of product safety and vigilant consumer awareness. Embracing a proactive approach to health, particularly when it comes to products intended for eye care, is essential for personal well-being. Stay informed, stay safe.

Source: https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-eye-drops-several-major-brands-due-risk-eye

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