The US Food and Drug Administration (FDA) has issued an urgent warning after multiple cases of severe infections, vision loss, and even deaths were linked to contaminated eye drops. The affected products, manufactured by Global Pharma Healthcare in India, include EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears, which have now been recalled.
What Are the Risks?
The FDA has identified a rare strain of drug-resistant bacteria called Pseudomonas aeruginosa in the recalled eye drops. This pathogen can cause severe infections leading to permanent vision loss, bloodstream infections, and in extreme cases, death. At least 55 patients across 12 US states have reported infections, with some requiring hospitalization.
Which Products Are Affected?
- EzriCare Artificial Tears (all lots)
- Delsam Pharma’s Artificial Tears (all lots)
- Delsam Pharma’s Artificial Eye Ointment (all lots)
The FDA has urged consumers to immediately stop using these products and consult a healthcare provider if they experience symptoms such as eye pain, redness, or blurred vision.
What Should You Do?
If you have used any of these products, the FDA recommends:
- Discontinuing use immediately.
- Seeking medical attention if you experience symptoms.
- Reporting adverse reactions to the FDA’s MedWatch program.
This incident highlights the importance of regulatory oversight in pharmaceutical manufacturing, particularly for over-the-counter products. The FDA continues to investigate the source of contamination.
