Health
FDA Warns Consumers not to Purchase or Use Certain Eye Drops due to infection Risk
(CTN News) – The U.S. Food and Drug Administration (FDA) has raised concerns about more than two dozen over-the-counter eye drop products, citing potential risks of eye infections that could lead to vision loss.
This latest alert comes after FDA investigators discovered bacterial contamination in critical drug production areas of a manufacturing facility.
The affected products are from well-known brands, including CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up&Up, and Velocity Pharma.
The FDA’s Action
The FDA issued a strong recommendation for the manufacturers to recall the affected products, signaling the severity of the issue. Retailers like CVS, Rite Aid, and Target are already taking measures to remove these products from their store shelves and online platforms.
Products branded as Leader, Rugby, and Velocity may still be available, but consumers are advised not to purchase them. Fortunately, as of now, none of these products have caused any adverse effects in consumers.
Previous Contamination Warnings
This recent warning is part of a series of alerts issued by the FDA regarding the potential contamination of eye drop products. Just two months prior, the FDA urged consumers to discontinue using two specific eye drop products due to bacterial and fungal contamination. These contaminated products included LightEyez MSM Eye Drops Eye Repair and Dr. Berne’s MSM Drops 5% Solution.
In February, the Centers for Disease Control and Prevention (CDC) reported an outbreak of infections linked to Pseudomonas aeruginosa, a drug-resistant bacteria strain. This outbreak was tied to the contamination of various brands of artificial tears and eye drops.
The CDC identified 81 cases of infection, with four individuals sadly losing their lives due to these infections.
Multiple brands were associated with these infections, with the most common culprit being Ezri Care Artificial Tears from India-based Global Pharma Healthcare.
The FDA criticized Global Pharma for inadequate microbial testing of their eye products, improper tamper-resistant packaging, and the distribution of drugs without adequate preservatives.
Two additional companies recalled eye drop products in February, although these products were not initially linked to the infections.
Eye drops and gels recalled by the FDA
CVS Health:
- Lubricant Eye Drops 15 ml (single pack)
- Lubricant Eye Drops 15 ml (twin pack)
- Lubricant Gel Drops 15 ml (single pack)
- Lubricant Gel Drops 15 ml (twin pack)
- Multi-Action Relief Drops 15 ml
- Lubricating Gel drops 10 ml
- Lubricant Eye Drops 10 ml (single pack)
- Lubricant Eye Drops 10 ml (twin pack)
- Mild Moderate Lubricating Eye Drops 15 ml (single pack)
Rugby (Cardinal Health):
- Lubricating Tears Eye Drops 15 ml
- Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml
Leader (Cardinal Health):
- Dry Eye Relief 10 ml
- Lubricant Eye Drops 15 ml (single pack)
- Lubricant Eye Drops 15 ml (twin pack)
- Dry Eye Relief 15 ml
- Eye Irritation Relief 15 ml
Conclusion
The FDA’s latest warning on the potential infection risk associated with over-the-counter eye drop products is a vital reminder of the importance of product safety and quality control.
Consumers are urged to check their medicine cabinets for any affected products and cease using them immediately. The FDA’s diligence in monitoring and issuing these warnings serves as a crucial safeguard for public health, ensuring that the safety and well-being of consumers remain a top priority in the healthcare industry.
