An artificial tears eye drops marketed by EzriCare in the United States has been recalled after more than 55 people in 12 states suffered serious infections. Manufactured in India by Global Pharma Healthcare, the Food and Drug Administration (FDA) advised that the products be recalled after they were found to have been contaminated by the bacteria Pseudomonas aeruginosa.
According to the FDA, some sealed bottles of EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears – both products marketed under different brands by EzriCare – were recalled because they caused an outbreak of drug-resistant infections in several states. The Centers for Disease Control and Prevention (CDC) reported that five people suffered permanent blindness, and one person in Washington died of a blood infection after using the eye drop products.
The FDA has issued an alert to doctors and consumers to stop using the listed products. The eye drops have also been prohibited from being imported into the United States. Artificial tears eye drops are basically used to lubricate the eyes in cases of eye irritation and dryness. The products are preservative-free, meaning that they do not contain active ingredients that prevent bacterial growth in them.
New Jersey-based EzriCare said in a statement that after learning about the investigation on January 20, it “immediately took action to stop any further distribution or sale of EzriCare Artificial Tears. To the greatest extent possible, we have been contacting customers to advise them against the continued use of the product.”
Infections were diagnosed in patients in California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah, Washington, and Wisconsin. Some patients were hospitalized after using the over-the-counter eye drops.
Although Pseudomonas aeruginosa is a bacterium commonly found in water and soil around us, it can also be found in hospitals and medical clinics, the CDC stated. It is highly resistant to most antibiotics, but researchers are testing its susceptibility to the antibiotic cefiderocol. The bacteria in eye drops can enter the tear ducts and move to the nasal cavity, from where they travel into the lungs and the bloodstream.