The Food and Drug Administration is warning New York State residents about a recall of eye drops and eye ointment. The eye drop recall was issued at the beginning of February. Yesterday, Tuesday, February 21, 2023, the FDA issued a warning to consumers in New York and nationwide to avoid the eye ointment,

Artificial Tears products, FDA is also now warning consumers and health care professionals not to purchase or use Delsam Pharma’s Artificial Eye Ointment due to potential bacterial contamination. This is an over-the-counter product, manufactured by Global Pharma Healthcare Private Limited, intended to be sterile.

On February 2, the FDA issued a warning about  EzriCare artificial tears products. The Centers for Disease Control is warning that one brand may be responsible for causing infections and deaths. The CDC is investigating a cluster of Verona Integron‐mediated Metallo‐β‐lactamase- and Guiana‐Extended Spectrum‐β‐Lactamase‐producing carbapenem‐resistant Pseudomonas aeruginosa eye infections. Recent laboratory evidence links the infections to one brand of eye drops.


 

To date, there are 55 reports of adverse events including eye infections, permanent loss of vision, and a death with a bloodstream infection.

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CDC
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According to the CDC,

Pseudomonas is a type of bacteria (germ) that is found commonly in the environment, like in soil and in water. Of the many different types of Pseudomonas, the one that most often causes infections in humans is called Pseudomonas aeruginosa, which can cause infections in the blood, lungs (pneumonia), or other parts of the body after surgery.

There have been 50 cases in New York and 10 other states, including California, Colorado, Connecticut, Florida, New Jersey, New Mexico, Nevada, Texas, Utah and Washington. The infections, which have been reported from May 17, 2022, to January 19. 2023, have led to hospitalizations and permanent vision loss. One case resulted in death. The CDC said in a news release,

CDC recommends that clinicians and patients immediately discontinue the use of EzriCare Artificial Tears until the epidemiological investigation and laboratory analyses are complete.

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FDA
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FDA
FDA
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While investigating possible causes of the widespread cases, CDC investigators determined that the majority of people suffering from the infections had used eye drops with EzriCare being the most frequently used. The bacteria was found in open bottles of the EzriCare artificial tears. The CDC is continuing to test sealed bottles of the product.

EzriCare says it has stopped selling the eye drops.

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