Manufacturer recalls eye drops linked to one death and vision loss in an outbreak across 12 states
A manufacturer on Thursday recalled eye drops linked to possible cases of bacterial infection.
The CDC said last month to stop using the EzriCare eye drops.
The recommendation is a precaution after 55 people tested positive for a drug-resistant bacterium.
An India-based manufacturer recalled its brand name EzriCare artificial tears on Thursday after the Centers for Disease Control and Prevention said the eye drops could be contaminated with a drug-resistant bacterium.
The CDC warned people to stop using the eyedrops last month and said the recommendation was a precaution after it received reports of "permanent vision loss" resulting from eye infections and one person died from a bloodstream infection. It said the people had tested positive for a multi-drug-resistant bacterium.
Global Pharma Healthcare, which makes the Artificial Tears lubricant eye drops, announced the voluntary recall of the eyedrops on Thursday. The product was distributed throughout the United States over the internet, the statement said.
In a Wednesday statement, EzriCare said it had "no rule" in formulating, packing, or manufacturing the product, and only designed the label and contributed marketing for the eye drops.
On Wednesday the CDC said 55 patients across 12 states (California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah, Washington, and Wisconsin) had tested positive for a strain of Pseudomonas aeruginosa that hasn't been detected in the US before.
Most patients had used EzriCare Artificial Tears
It added that most of the people with positive samples said they'd used eye drops before testing and that the most commonly mentioned brand was EzriCare Artificial Tears. The CDC said the samples were taken from patients in hospitals and outpatient clinics from May to December.
Pseudomonas aeruginosa, which can cause infections in the blood, in the lungs, or in wounds, is becoming more difficult to treat as it evolves defense mechanisms against antibiotics, known as antibiotic resistance. The CDC says the bacteria usually spreads to people in hospitals or other healthcare settings when they're exposed to contaminated water or soil, where it typically lives.
The strain of Pseudomonas aeruginosa that was found is resistant to carbapenems, or powerful antibiotics designed to kill bacteria that cause diseases like pneumonia, urinary infections, and severe skin infections. It's also resistant to two other antibiotics, called ceftazidime, which doctors use for urinary infections, meningitis, and bloodstream infections, and cefepime, which can also be used for urinary infections.
CDC lab testing found the strain behind the outbreak in opened EzriCare bottles with different lot numbers collected from two states, the agency said on Wednesday.
"Testing of unopened bottles of EzriCare Artificial Tears is ongoing to assist in evaluating for whether contamination may have occurred during manufacturing," it said on Wednesday, prior to the recall.
Stop using EzriCare Artificial Tears as a precaution
The CDC recommended on January 20 that clinicians and patients "immediately discontinue the use of EzriCare Artificial Tears until the epidemiological investigation and laboratory analyses are complete."
It said people should see a doctor "immediately" if they experience any symptoms of an eye infection after using the drops.
EzriCare said in a statement on January 24 that the CDC hadn't asked the company to recall products and that it hadn't received any "consumer complaints or adverse event report related to the investigation."
"In an abundance of caution, EzriCare recommends that during this evolving situation you DISCONTINUE USE of any portions of EzriCare Artificial Tears Lubricant Eye Drops you may have until we can discover more details about any potential safety concerns," it said.
EzriCare said in another statement on Wednesday that it was unaware of testing that had "definitively" linked the Pseudomonas aeruginosa outbreak to EzriCare Artificial Tears. But it said it had stopped selling the product, which is manufactured in India by Global Pharma Healthcare PVT Limited and marketed under other brand names as well.
"We understand that Global Pharma Healthcare PVT Limited will be initiating a recall of the product, but as of the date and time of this Press Release that has not happened," EzriCare said.
Global Pharma Healthcare PVT Limited did not immediately respond to a request for comment.
February 2, 2023: This story has been updated to include Global Pharma Healthcare's recall announcement.
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