CDC recommends against use of EzriCare Artificial Tears due to link with infection
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The CDC issued a statement recommending that clinicians and patients discontinue using EzriCare Artificial Tears due a possible link to eye infections that have led to vision loss, hospitalization and death.
The CDC said it is investigating a multistate cluster of Pseudomonas aeruginosa in partnership with state and local health departments. Between May 17, 2022, and Jan. 19, 2023, 56 isolates were identified among 50 patients in 11 states: California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah and Washington. The P. aeruginosa showed resistance to carbapenem, ceftazidime and cefepime. One patient died from a bloodstream infection.
It was determined that the majority of patients used artificial tears prior to infection, with the most common brand used being preservative-free EzriCare Artificial Tears, available in multidose bottles.
“Laboratory testing of EzriCare Artificial Tears by CDC identified the presence of [the resistant P. aeruginosa] in opened EzriCare bottles,” according to the statement. “CDC recommends that clinicians and patients immediately discontinue the use of EzriCare Artificial Tears until the epidemiological investigation and laboratory analyses are complete.”
In a Feb. 1 statement on its website, EzriCare LLC said it was first contacted by the CDC Jan. 20 regarding the investigation.
“As of today, we are not aware of any testing that definitively links the P. aeruginosa outbreak to EzriCare Artificial Tears,” the company said. “Nonetheless, we 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 continued use of the product. We also immediately reached out to both the CDC and FDA and indicated our willingness to cooperate with any requests they may have of us.”
EzriCare further said that the product is manufactured by India-based Global Pharma Healthcare PVT Ltd., imported into the U.S. by Aru Pharma Inc. and marketed other brand names. EzriCare provides only labeling and marketing.
“We understand that Global Pharma Healthcare PVT Ltd. will be initiating a recall of the product, but as of the date and time of this press release that has not happened,” EzriCare stated. “We understand that [Global Pharma] is currently working with FDA on that issue.”
Editor’s note: On April 6, 2023, the image accompanying this article was changed. Healio regrets any confusion caused by the previous image.
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