Eye drops recall by manufacturer linked to one eye injury and one death in an epidemic that swept across 11 states

After the Centers for Disease Control and Prevention stated that eye drops may have been contaminated by a drug-resistant bacteria, an India-based manufacturer recalls its brand EzriCare artificial tear brand.

After receiving reports of permanent vision loss due to eye infections, the CDC advised people not to use eyedrops. One person also died from a bloodstream infection. The CDC stated that the individuals had been tested positive for a multidrug-resistant bacterium.

Global Pharma Healthcare is the manufacturer of Artificial Tears Lubricant eye drops. On Thursday, the voluntary recall was announced. According to the statement, the product was distributed across the United States via the internet.

EzriCare stated in a Wednesday statement that it followed no rules when formulating, packing or manufacturing the product and that it only designed the label and participated in marketing for the eye drops.

On January 20, , 50 people from 11 states (California Colorado, Connecticut, Florida New Jersey, New Mexico New York, Nevada Texas, Utah and Washington) tested positive for the bacterium Pseudomonas aeruginosa.

The CDC stated that most people who had positive eye samples reported that they used eye drops before testing. EzriCare Artificial Tears was the most popular brand. According to the CDC, samples were collected from patients at outpatient clinics and hospitals between May and December.

Pseudomonas Aeruginosa can cause infection in blood, lungs or wounds. This bacteria is developing resistance mechanisms to antibiotics that make it more difficult to treat. According to the CDC, bacteria can spread to patients in hospitals and other healthcare settings if they are exposed to contaminated soil or water.

Pseudomonas is aeruginosa strain found to be resistant to carbapenems. These powerful antibiotics are designed to kill bacteria that causes diseases such as pneumonia, severe skin infections, and urinary infections. It is also resistant to ceftazidime (used by doctors for meningitis and urinary infections) and cefepime (used for urinary infection).

According to the CDC, lab tests of EzriCare eye drop bottles opened by EzriCare detected another type Pseudomonas aeruginosa.

They said that the bacteria was being tested to confirm if it matches the outbreak strain.

It stated that “Testing of unopened EzriCare Artificial Tears bottles is ongoing.”

On January 20, the CDC advised that patients and clinicians “immediately cease using EzriCare artificial tears until further epidemiological investigation and laboratory analysis are completed.”

EzriCare stated in a statement dated January 24, that the CDC had not asked the company to recall its products and that it hadn’t received any consumer complaints or adverse events reports related to the investigation.

EzriCare advised that you discontinue the use of any EzriCare Artificial Teers Lubricant Eye Drops during this changing situation until we have more information about potential safety concerns.

EzriCare stated in a further statement Wednesday that it wasn’t aware of any testing that had “definitively linked” the Pseudomonas aeruginosa epidemic to EzriCare Artificial Tears. It said that it had stopped selling the product. The product is manufactured in India at Global Pharma Healthcare PVT Limited.

EzriCare stated that while Global Pharma Healthcare PVT Limited has indicated that they will recall the product, it was not yet happening.

Global Pharma Healthcare PVT Limited didn’t immediately respond to a request.

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