FDA expands contaminated eye product warning due to potential bacterial contamination, risk of blindness – The Denver Post

Muri Assunção | (TNS) New York Daily News

The Food and Drug Administration is adding to a list of eye-care products consumers should stop using “immediately” over concerns of possible bacterial contamination that could lead to blindness if infection occurs.

The FDA is “warning consumers and health care professionals not to purchase or use Delsam Pharma’s Artificial Eye Ointment due to potential bacterial contamination,” the agency announced Tuesday.

The ointment, which is manufactured by Global Pharma Healthcare Private Limited, is a lubricant used to prevent irritation and relieve dryness of the eye, according to a description on Delsam Pharma’s website.

The announcement comes three weeks after the agency issued a similar warning against two other Global Pharma products, artificial tears distributed by EzriCare and Delsam Pharma.

“Using contaminated artificial tears increases (the) risk of eye infections that could result in blindness or death,” the FDA said in a news release on Feb.2.

“Patients who have signs or symptoms of an eye infection should talk to their health care provider or seek medical care immediately,” the agency added.

All three products are manufactured by Global Pharma and sold over the counter. They are intended to be sterile.

Global Pharma announced a voluntary recall of all unexpired lots of the artificial tears products shortly after the Centers for Disease Control and Prevention issued a health advisory over an outbreak of a “rare strain of extensively drug-resistant” bacteria, Pseudomonas aeruginosa, associated with the use of the eye drops.

The recall was recommended by the FDA due to the company’s “current good manufacturing practice (CGMP) violations,” which include the distribution of the drug in multi-use bottles without adequate preservatives, and the lack of appropriate microbial testing.

As of Tuesday, the CDC had identified 58 patients in 13 states with infections that have been linked to the use of contaminated products.

One person died due to a bloodstream infection, and five people reportedly lost their vision, according to a news release.

EzriCare Artificial Tears was the brand most commonly reported.

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