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FDA Alerts Public: Safety Concerns Surrounding Over-the-Counter Eye Drops

Warning Issued for Products – Potential Risks to Vision, Could Cause Blindness

By Dolores Quintana

The U.S. Food and Drug Administration (FDA) is issuing a warning regarding 26 over-the-counter (OTC) eye drop products due to potential safety concerns related to the risk of eye infections that may result in partial vision loss or blindness. Consumers are strongly advised not to purchase or use these products. If individuals experience any signs or symptoms of an eye infection after using these products, they should promptly consult with a healthcare provider or seek immediate medical attention. This is the updated list as of October 30, 2023.

These eye drop products are marketed under various brand names, including:

  • CVS Health
  • Leader (Cardinal Health)
  • Rugby (Cardinal Health)
  • Rite Aid
  • Target Up & Up
  • Velocity Pharma

It is important to note that these OTC eye drop products are intended to be sterile. Ophthalmic drug products, which are applied to the eyes, pose a heightened risk to users since they bypass certain natural defense mechanisms in the body.

On October 25, 2023, the FDA recommended that the manufacturer of these products initiate a recall of all lots. This decision followed FDA investigators’ findings of unsanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility. As a precaution, the FDA also advises consumers to properly dispose of these products.

Retailers, including CVS, Rite Aid, and Target, are taking measures to remove these 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, and consumers are strongly discouraged from acquiring these items.

At this time, the FDA has not received any reports of adverse events related to eye infections associated with the use of these products. The FDA encourages both healthcare professionals and patients to report any adverse events or quality issues with medications through the FDA’s MedWatch Adverse Event Reporting program. Reports can be submitted online via Medwatch or by downloading and completing the reporting form and faxing it to 1-800-FDA-0178.

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