Eye drops recalled after being linked to vision loss and death
Maker of artificial tears EzriCare said it was recalling eye drops after US health authorities linked the product to a resistant bacterial strain medication.
The maker of an over-the-counter eye drop brand said it was recalling the product, EzriCare Artificial Tears, after it was linked to a drug-resistant bacterial strain that caused at least one person died and lost their sight in five others.
The Centers for Disease Control and Prevention has advised people to stop using the eye drops, as the agency investigates an outbreak of a strain of the bacterium pseudomonas aeruginosa, which can cause infections in the blood, lungs and other parts of the body. This strain of the bacteria had never been identified in the United States before the current outbreak and is resistant to a class of antibiotics called carbapenems, which are generally considered a last resort.
The bacterial strain had been found in 55 people in 12 states as of Tuesday, the C.D.C. said. The agency said the infections caused one death, loss of vision in five of 11 people who had eye infections and some hospitalizations.
The Food and Drug Administration said Thursday night that the recall also included Delsam Pharma's artificial tears, which are made by Global Pharma, the Indian company that makes EzriCare eye drops. Global Pharma said it was recalling the eye drops "out of an abundance of caution".
"Global Pharma is fully cooperating with U.S. federal authorities and continues to investigate this issue, but so far we have not determined whether our manufacturing facility is the source of the contamination," the company said in an emailed statement.
Most people affected by the outbreak used artificial tears before infections, the C.D.C. said. They had reported using more than 10 brands of artificial tears, and some patients used more than one , but EzriCare Artificial Tears is the most common brand, the agency said.
The CDC said it found the drug-resistant bacterial strain in open vials of EzriCare eye drops collected from patients with and without infection s eyepieces. The agency is testing unopened bottles to determine if contamination occurred during the manufacturing process.
The bacterial strain was found in people in California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah, Washington and Wisconsin between May 2022 and January, according to the C.D.C. Of those 55 cases, 35 were linked to four groups of healthcare facilities, the agency said.
The C.D.C. said people who have used EzriCare artificial tears and show signs of eye infection should seek medical attention immediately. Symptoms may include yellow, green, or clear discharge from the eye, redness of the eye or eyelid, increased sensitivity to light, and eye pain or discomfort.
Maker of artificial tears EzriCare said it was recalling eye drops after US health authorities linked the product to a resistant bacterial strain medication.
The maker of an over-the-counter eye drop brand said it was recalling the product, EzriCare Artificial Tears, after it was linked to a drug-resistant bacterial strain that caused at least one person died and lost their sight in five others.
The Centers for Disease Control and Prevention has advised people to stop using the eye drops, as the agency investigates an outbreak of a strain of the bacterium pseudomonas aeruginosa, which can cause infections in the blood, lungs and other parts of the body. This strain of the bacteria had never been identified in the United States before the current outbreak and is resistant to a class of antibiotics called carbapenems, which are generally considered a last resort.
The bacterial strain had been found in 55 people in 12 states as of Tuesday, the C.D.C. said. The agency said the infections caused one death, loss of vision in five of 11 people who had eye infections and some hospitalizations.
The Food and Drug Administration said Thursday night that the recall also included Delsam Pharma's artificial tears, which are made by Global Pharma, the Indian company that makes EzriCare eye drops. Global Pharma said it was recalling the eye drops "out of an abundance of caution".
"Global Pharma is fully cooperating with U.S. federal authorities and continues to investigate this issue, but so far we have not determined whether our manufacturing facility is the source of the contamination," the company said in an emailed statement.
Most people affected by the outbreak used artificial tears before infections, the C.D.C. said. They had reported using more than 10 brands of artificial tears, and some patients used more than one , but EzriCare Artificial Tears is the most common brand, the agency said.
The CDC said it found the drug-resistant bacterial strain in open vials of EzriCare eye drops collected from patients with and without infection s eyepieces. The agency is testing unopened bottles to determine if contamination occurred during the manufacturing process.
The bacterial strain was found in people in California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah, Washington and Wisconsin between May 2022 and January, according to the C.D.C. Of those 55 cases, 35 were linked to four groups of healthcare facilities, the agency said.
The C.D.C. said people who have used EzriCare artificial tears and show signs of eye infection should seek medical attention immediately. Symptoms may include yellow, green, or clear discharge from the eye, redness of the eye or eyelid, increased sensitivity to light, and eye pain or discomfort.
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