the health strategist
institute for strategic health transformation
& digital technology
Joaquim Cardoso MSc.
Chief Research and Strategy Officer (CRSO),
Chief Editor and Senior Advisor
November 2, 2023
One page summary
What is the message?
The FDA has issued a warning regarding 27 eye drop products sold at major retailers, such as CVS, Target, Walmart, Rite Aid, and others, due to concerns about potential bacterial contamination, which could lead to eye infections.
Consumers must discontinue the use of these products. Vigilance is also important in ensuring the safety of eye drop products, particularly given the potential risks associated with eye infections, which can lead to vision issues, including blindness.
What are the key points?
FDA Warning:
The FDA has identified 27 eye drop products that may not be sterile and could pose a risk of eye infections. This warning affects well-known brands like CVS Health, Target Up & Up, Walmart, Rite Aid, Leader (Cardinal Health), Rugby (Cardinal Health), and Velocity Pharma.
Recall:
Cardinal Health, specifically the Leader brand, has issued a voluntary recall for six eye drop products in response to the FDA’s warning. The company has reported three adverse events related to these products.
Bacterial Contamination:
FDA investigations revealed that the implicated eye drop products were manufactured in conditions considered “insanitary,” with multiple production areas testing positive for bacteria during environmental sampling tests.
Previous Warnings:
This warning is not an isolated incident. The FDA has recently cautioned against using other non-sterile eye drops, including Dr. Berne’s, LightEyez, and EzriCare, which had bacterial contamination, leading to hospitalizations and even a death.
Increased Oversight:
The FDA has intensified its oversight, particularly for private label or less-established eye drop manufacturers, to prevent potential health issues caused by contaminated products.
Consumer Safety:
The FDA emphasizes that larger manufacturers and well-known eye drop brands maintain stringent quality control and sterilization practices, ensuring the safety of their products.
Statistics
- Cardinal Health’s Leader brand recalled six eye drop products due to the FDA’s warning, with reports of three adverse events related to these products.
- The FDA has not reported additional eye infections beyond the three adverse reactions linked to the Leader (Cardinal Health) brand eye drops.
- In the case of the EzriCare eye drops, the product was contaminated with antibiotic-resistant Pseudomonas bacteria, making treatment challenging and posing potential health risks.
Examples
- In recent months, the FDA warned against using Dr. Berne’s, LightEyez, and EzriCare eye drops due to similar issues. The contamination in the case of EzriCare led to hospitalizations and one death.
- Large manufacturers and well-established eye drop brands maintain high-quality control and sterilization practices, assuring the safety of their products.
Conclusion
The FDA’s warning regarding 27 eye drop products highlights the agency’s commitment to consumer safety.
Consumers should immediately discontinue the use of these affected products, especially those from Cardinal Health’s Leader brand, which has initiated a recall due to reported adverse events.
Although concerns have arisen about some products, most established eye drop brands are considered safe for use.
DEEP DIVE
This summary was written based on the article “FDA Warning: 27 Eye Drop Products Could Cause Eye Infections”, published by Health.com and written by Julia Landwehr, on November 1, 2023.
To read the original publication, click here.
