It’s been several months since Global Pharma Healthcare issued sweeping recalls of three eye drops after researchers linked them to eye infections caused by Pseudomonas aeruginosa, a bacterium never before found in the eye. In some cases, the infections have led to permanent disability, disfigurement, and even death.
In this blog post, we’ll take a closer look at the source of the contamination, what infections and conditions are linked to recalled EzriCare eye drops, and how you may be able to recover compensation if the recalled eye drops harmed you or a loved one.
What Eye Drops Were Recalled?
The recalled eye drops were manufactured by Global Pharma Healthcare and distributed by either Delsam Pharma or EzriCare, LLC. The recalled eye drops include:
- EzriCare Artificial Tears
- Delsam Pharma’s Artificial Tears
- Delsam Pharma’s Artificial Eye Ointment
What is Pseudomonas aeruginosa?
P. aeruginosa, the bacterium linked to cases of eye infections and related complications from EzriCare- and Delsam Pharma-brand eye drops and ointments has been around for years. It lives naturally in the environment and can spread to people when exposed to P. aeruginosa-contaminated water or soil.
P. aeruginosa can cause infections such as swimmer’s ear. Individuals with compromised immune systems are especially vulnerable. In 2020, the bacteria made its way around U.S. hospitals, infecting an estimated 28,800 patients. Resistant strains found in healthcare settings are often spread from person to person through contaminated hands and equipment.
What’s Unusual About P. aeruginosa Eye Infections?
While P. aeruginosa infections aren’t unusual, they’re not usually found in the eye. This gave researchers pause after identifying the bacterium in a sample taken from a patient diagnosed with a corneal ulcer caused by an eye infection. This was November 2022, two months before the U.S. Centers for Disease Control and Prevention (CDC) alerted the public that it was investigating a cluster of P. aeruginosa eye infections.
Even more puzzling was the strain found in the patient was different from anything found in the U.S. before — carbapenem-resistant Pseudomonas aeruginosa with Verona integron-mediated metallo β-lactamase and Guiana extended-spectrum-β-lactamase. The lengthy name shows how it’s mutated over time to become even more drug-resistant.
Microbiologists and infectious disease experts eventually traced the source to contaminated eye drops manufactured by Global Pharma Healthcare, which ultimately led to the February 2023 recalls of three of the company’s eye drops — EzriCare Artificial Tears, Delsam Pharma Artificial Tears, and Delsam Pharma Artificial Eye Ointment.
Who is at Greater Risk for Complications from the Recalled Eye Drops?
The recalled EzriCare and Delsam Pharma eye drops were sold over the counter without a prescription at retail stores such as Walmart. People who would most likely use artificial tears include contact wearers, people with glaucoma, dry-eye sufferers, and anyone looking to relieve dry, itchy eyes. Researchers believe that it is unlikely for healthy individuals to develop infections or serious complications from using eye drops contaminated with P. aeruginosa.
However, vulnerable populations, including immunocompromised people, who have existing cornea damage, or other health conditions, are at greater risk of infection and complications. Many of the cases of infection identified by the CDC were among individuals living in long-term care facilities. The Connecticut Department of Public Health, for example, has seen at least 26 cases of infection since June 2022, most of which have been residents in long-term care facilities.
Are People Still Suffering from Eye Drop Infections or Complications?
In February, the CDC urged anyone who had bottles of the recalled eye drops in their possession to stop using them immediately due to the risk of infection. But, public health officials worry that some people may still have the recalled eye drops in their medicine cabinets. Those who do may accidentally use them and be at risk for infection.
The CDC urges anyone who develops symptoms of eye infection to seek immediate medical attention.
Symptoms of eye infection may include:
- Pain in the eye
- Redness or dryness in the eye or eyelid
- Yellow, green, or clear eye discharge
- A feeling that something is in the eye
- New or worsening light sensitivity
- Blurred vision
How Did EzriCare Eye Drops Become Contaminated?
Weeks after Global Healthcare Pharma issued a recall of ErziCare eye drops, the U.S. Food and Drug Administration (FDA) launched an investigation into the pharmaceutical company’s labs and found dozens of issues and violations of Current Good Manufacturing Practice (CGMP). The violations included poor cleaning procedures, discolored clothing in cleanrooms, and “black, brown greasy deposits” on machinery used to fill product into bottles. Officials reported that the lab’s manufacturing process “lacked assurance of product sterility.”
Shortly after the first recall was announced, the first EzriCare eye drop lawsuit was filed against Global Pharma Healthcare by a Florida woman who developed “unrelenting pain in her eyes” after using the eye drops.
Talk to a Lawyer About Your EzriCare Eye Drop Case
If you or a loved one developed an eye infection or suffered complications after using one of the recalled ErziCare or Delsam Pharma eye products, you may be eligible to recover compensation for your medical bills and other losses. Contact the Lawsuit Legal News team at 866-467-0943 or complete our online contact form for a free consultation today.