Federal health officials recently linked a cluster of serious bacterial infections to an eye drop product called EzriCare Artificial Tears. Now, the product's manufacturer, Global Pharma Healthcare, is voluntarily recalling all lots of the product within expiry "due to possible contamination," the U.S. Food and Drug Administration (FDA) announced Thursday (Feb. 2).
The U.S. Centers for Disease Control and Prevention (CDC) previously advised doctors and consumers to stop using EzriCare Artificial Tears, as the agency had uncovered evidence that the product may be linked to dozens of drug-resistant bacterial infections across the country. The infections were caused by the bacterium Pseudomonas aeruginosa, a germ that usually poses the highest risk of infection to hospitalized people with surgery or burn wounds, as well as those who use ventilators or catheters.
The strain of P. aeruginosa behind the outbreak is "rare" and "extensively drug-resistant," the CDC Health Alert Network reported on Feb. 1. So far, the agency has identified 55 cases of infection in 12 states that took place between May 2022 and January 2023. "Patient outcomes include permanent vision loss resulting from cornea infection, hospitalization, and one death due to systemic infection," the agency reported.
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Most people infected reported using artificial tears prior to falling ill; in all, they reported using 10 different eye drop brands, and some individuals used multiple.
However, "the majority of patients who used artificial tears reported using EzriCare Artificial Tears, a preservative-free, over-the-counter product packaged in multidose bottles," the CDC reported. "CDC laboratory testing identified the presence of the outbreak strain in opened EzriCare bottles with different lot numbers collected from two states."
Global Pharma Healthcare is specifically recalling a product called "Artificial Tears Lubricant Eye Drops," which is manufactured in India and distributed by both Delsam Pharma and Aru Pharma Inc; the latter distributor provides the product to EzriCare, which sells EzriCare Artificial Tears, according to a statement from the company. EzriCare had already recommended that consumers stop using the eye drops on Jan. 24, after the company learned of the CDC's ongoing investigation.
"Global Pharma Healthcare is notifying the distributors of this product, Aru Pharma Inc. and Delsam Pharma and is requesting that wholesalers, retailers and customers who have the recalled product should stop use," the recent FDA announcement reads.
