In the late spring of 2022, doctors began noticing patients with bacterial eye infections resistant to drugs often used to treat these infections. Many of these patients developed severe complications, including vision loss, disfigurement, and death. Months later, the U.S. Center for Disease Control and Prevention (CDC) would identify the strain of bacteria and trace it to bottles of over-the-counter EzriCare- and Delsam Pharma-brand eye drops made by Global Pharma Healthcare.
Here’s a recalled EzriCare eye drop timeline and the latest count of infections and deaths linked to the products.
EzriCare Recall Timeline
June 1, 2022
Judy Gregory, 81, of Elsmere, Kentucky, is hospitalized with a severe eye infection after using EzriCare Artificial Tears to treat dry eyes. Doctors managed to save her eye, but she continued to suffer from vision loss several months later.
Late Summer 2022
Dr. Guillermo Amescua, a cornea specialist, tells NBC News that he began noticing “something weird” about eye infections in patients he saw at the Bascom Palmer Eye Institute of the University of Miami Miller School of Medicine. Pseudomonas is a common bacterium that can infect contact lens wearers and are usually easily treated with antibiotics. But at least seven cases he encountered were resistant to the drugs he prescribed. “I was getting complication after complication,” Dr. Amescua said. “I don’t remember in my 10-plus years losing the battle against a Pseudomonas infection so many times in such a short period of time.”
November 2022
Doctors in Cleveland diagnose a 72-year-old patient suffering a corneal ulcer with a Pseudomonas Aeruginosa infection, an antibiotic-resistant strain of Pseudomonas that had not been recovered from an eye before. Infectious disease physicians later identified her contaminated eye drops as the source of the infection.
December 2022
The U.S. Food and Drug Administration (FDA) learns that the CDC is investigating an outbreak of P. aeruginosa, and that the agency was investigating many products as the potential source of infection.
January 20, 2023
The CDC announces that it is investigating a multistate cluster of infections involving the antibiotic-resistant bacteria P.aeruginosa associated with different types of infections, including eye infections. Recent epidemiology and laboratory evidence link the infections to EzriCare Artificial Tears.
In partnership with state and local health departments, the CDC identified infections in 50 patients from 11 states from May 17, 2022, to January 19, 2023. Patient outcomes include permanent vision loss from ocular infection, hospitalization, and death of one patient with a bloodstream infection.
The CDC recommends clinicians and patients immediately discontinue using EzriCare Artificial Tears until the investigation is complete.
February 2, 2023
Global Pharma Healthcare recalls all lots of EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears due to potential bacterial contamination and the risk of infections that could result in blindness or death. The FDA cautioned patients who used the products and have signs or symptoms of infection to seek medical care immediately.
Symptoms of eye infection may include:
- Yellow, green, or clear eye discharge
- Eye pain or discomfort
- Redness of the eye or eyelid
- A sensation that something is in your eye
- Sensitivity to light
- Blurry vision
Since the CDC’s announcement two weeks prior, the number of infected patients grew to 55 in 12 states, linked by epidemiologic and laboratory evidence to using EzriCare Artificial Tears.
The FDA said it recommended Global Pharma Healthcare issue the recall “due to the company’s current good manufacturing practice (CGMP) violations, including lack of appropriate microbial testing, formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use bottles, without an adequate preservative), and lack of proper controls concerning tamper-evident packaging.”
February 9, 2023
A Florida woman files the first EzriCare eye drop lawsuit against Global Pharma Healthcare and Walmart in the U.S. District Court for the Middle District of Florida. According to her lawsuit, she developed “unrelenting pain in her eyes” just weeks after purchasing EzriCare eye drops. Antibiotics failed to stop the infection, and she had to undergo surgery to treat some of the associated problems. She continues to suffer from complications.
February 21, 2023
The FDA warns consumers and health care professionals not to purchase or use Delsam Pharma's Artificial Eye Ointment due to potential bacterial contamination. The warning comes after an analysis by the agency found unopened bottles of the product to be contaminated with bacteria. The FDA recommends the manufacturer, Global Pharma Healthcare, makers of the previously recalled EzriCare and Delsam Pharma's Artificial Tears, recall the ointment due to the risk of infection.
February 24, 2023
Global Pharma Healthcare complies with the FDA's request and expands the Delsam Pharma and EzriCare eye drop recall to include Delsam Pharma’s Artificial Eye Ointment.
April 3, 2023
CBS News reports the findings of an FDA inspection of Global Healthcare Pharma's labs from February 20 to March 2. According to the report, inspectors found dozens of issues at the plant, including poor cleaning procedures, inadequate training of workers, discolored booties in cleanrooms, "black, brown greasy deposit" on one of the machines used to fill product into bottles, and a "manufacturing process that lacked assurance of product sterility."
May 15, 2023
The CDC issues an update on the EzriCare eye drop recall, reporting P. aeruginosa infections in 81 patients across 18 states. Complications among those infected include 14 cases of vision loss, four enucleations (surgical removal of the eyeball), and four fatalities.
Harmed by Recalled EzriCare Eye Drops? Contact a Personal Injury Lawyer
Global Pharma Healthcare recalled EzriCare and Delsam eye drops and ointments after public health officials linked the products to serious infections resulting in severe pain, hospitalization, vision loss, disfigurement, and death. If you or a loved one suffered harm after using these recalled eye drops and ointments, you may be able to recover compensation for your medical bills and other losses through an EzriCare eye drop lawsuit. Contact the Lawsuit Legal News team today at 866-467-0943 or complete our online contact form to see if you qualify.