- The Washington Times - Tuesday, April 4, 2023

A drug-resistant strain of Pseudomonas aeruginosa, a bacteria linked to contaminated eyedrops, has been found to spread from person to person, according to the Centers for Disease Control and Prevention.

The strain has been tied to three eye care products produced by Global Pharma in the southern Indian state of Tamil Nadu: EzriCare Artificial Tears and Delsam’s Artificial Tears and Artificial Eye Ointment. All three products have been recalled.

An outbreak of the bacteria has spread to 16 states: California, Colorado, Connecticut, Florida, Illinois, North Carolina, Nevada, New Mexico, New Jersey, New York, Pennsylvania, South Dakota, Texas, Utah, Washington and Wisconsin.



The CDC said 68 people had reported infections as of March 14, with 37 of them linked to four geographic clusters of healthcare facilities. The outbreak has caused three deaths, eight reports of vision loss and four cases where the surgical removal of the eyeball was needed, according to the CDC.

The bacteria is capable of spreading from person to person, especially in the moisture-rich environments inside many health care facilities.

Global Pharma contended in a February statement that it had “not determined whether our manufacturing facility is the source of the contamination.”

The Food and Drug Administration has imposed a ban on importing Global Pharma products.

An unannounced FDA inspection at the company’s facility, the first ever performed by the FDA there, found a number of issues, including no proof that the facility’s equipment worked at sterilizing the solutions, a visual look-over was the only step in detecting leaks; non-standard filling of vials; and a lack of written procedures.

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Regulators in Tamil Nadu say they found no contamination in samples of unopened eye drops made at the plant.

The Tamil Nadu state regulator also found “no evidence of deviation” at the plant when production of U.S.-bound eye drops stopped in February, according to NDTV.

One expert was surprised EzriCare eyedrops ever made it to U.S. markets, as they do not use preservatives.

“I’m surprised that formulation was allowed to go on the market without more scrutiny. It’s kind of like the perfect storm,” Yale Health Plan chief of ophthalmology Vicente Diaz told the New York Times.

• Brad Matthews can be reached at bmatthews@washingtontimes.com.

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