Bacterial Contamination Identified in Indian Manufacturer’s Eyedrops, Warns US FDA


An eye drop made in India has been linked to the spread of a drug-resistant bacteria, resulting in infections, blindness, and one death in at least 55 patients, according to the US Food and Drug Administration (FDA).

The US FDA said that India’s Global Pharma Healthcare Pvt Ltd’s ‘Artificial Tears’ eye drop could be contaminated with bacteria and that the company broke current good manufacturing practices.

The eye drop was distributed in the United States by EzriCare LLC and Delsam Pharma. On Wednesday, the company, which has its headquarters in the southern Indian city of Chennai, stated that it had issued a voluntary recall at the consumer level for any remaining lots of the eye drop.

The US agency stated that it was working with state and local health departments, the Centers for Disease Control and Prevention (CDC), and a rare, extensively drug-resistant bacteria to investigate a multistate outbreak.

It stated that, as of the 31st of January, the CDC had identified 55 patients in 12 states who had contracted infections that were connected to the use of Artificial Tears that were distributed by EzriCare.

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The US FDA said that, associated adverse events include hospitalization, one death from bloodstream infection, and permanent eye infection vision loss.

In a statement, EzriCare said that it had stopped selling and distributing the eye drop anymore and did not know of any testing that “definitely links” the bacterial outbreak to the product.