An artificial tears product investigated by the Centers for Disease Control and Prevention has been recalled due to possible contamination, multiple infections and at least one death.
Global Pharma Healthcare manufactures EzriCare Artificial Tears, which has been linked to a germ called pseudomonas aeruginosa.
The company said Thursday that all lots are being recalled.
At least 55 patients have been impacted, suffering from eye infections, blindness and one death with a bloodstream infection, the company said this week.
Cases have been reported in at least 12 states including California, New Jersey and Florida. Patients have suffered from permanent vision loss and at least one person died from a bloodstream infection, the CDC said in a memo on Jan. 20.
“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 company said in its recall announcement.
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The recall comes after a CDC and FDA investigation on a “multistate outbreak of an extensively drug-resistant strain” of an infection. The strain, VIM-GES-CRPA, is new to the U.S.
“At this time, CDC recommends clinicians and patients stop using EzriCare Artificial Tears products pending additional guidance from CDC and FDA,” the CDC said on its website.
What’s EzriCare saying?
EzriCare said on its website that the company it is not aware of any testing that “definitively links” the outbreak to EzriCare Artificial Tears.
The company hasn’t received consumer complaints related to the investigation.
“We immediately took action to stop any further distribution or sale of EzriCare Artificial Tears,” the company wrote. “To the greatest extent possible, we have been contacting customers to advise them against continued use of the product.”
The company said Global Pharma Healthcare PVT Limited makes the product in India while Aru Pharma Inc. imports the product into the U.S.
“EzriCare, LLC’s only role in introducing the product to the market was to design an exterior label and to market it to our customers,” the company said, denying any role in the formulation, packaging delivery system design or manufacturing of the product in question.
Which states have been impacted?
Patients have been reported in:
- California
- Colorado
- Connecticut
- Florida
- New Jersey
- New Mexico
- New York
- Nevada
- Texas
- Utah
- Washington
- Wisconsin
The CDC said samples were collected between May 2022 and January 2023 and most patients had used artificial tears. The patients reported using 10 different brands of artificial tears, but EzriCare was the brand most commonly reported.
The CDC’s lab testing found the VIM-GES-CRPA strain in opened EzriCare bottles from multiple lots, the CDC said.
The agency is still testing unopened bottles of EzriCare Artificial Tears to see if contamination happened during manufacturing.
What are the symptoms?
The CDC said infection symptoms include:
- Yellow, green, or clear discharge from the eye
- Eye pain or discomfort
- Redness of the eye or eyelid
- Feeling of something in your eye (foreign body sensation)
- Increased sensitivity to light
- Blurry vision
I’ve used EzriCare Artificial Tears, what should I do?
Patients should stop using EzriCare Artificial Tears pending additional information from both the CDC and the FDA, the agencies said.
“Patients who have used EzriCare preservative-free artificial tears and who have signs or symptoms of an eye infection should seek medical care immediately,” the CDC said. “At this time, there is no recommendation for testing of patients who have used this product and who are not experiencing any signs or symptoms of infection.”
Saleen Martin is a reporter on USA TODAY’s NOW team. She is from Norfolk, Virginia – the 757 – and loves all things horror, witches, Christmas, and food. Follow her on Twitter at @Saleen_Martin or email her at sdmartin@usatoday.com.
