The US Food and Drug Administration has warned against using an India-made eye drop that has been linked to the outbreak of a drug-resistant bacteria leading to adverse events in at least 55 patients including infections, blindness and one death.
The agency said on Thursday that Artificial Tears eye drop manufactured by India's Global Pharma Healthcare Pvt Ltd has a potential bacterial contamination and the company has violated current good manufacturing practices.
The company, based in India's southern city of Chennai, on Wednesday said it had issued a voluntary recall at the consumer level of unexpired lots of the eye drop, which was distributed in the United States by EzriCare LLC and Delsam Pharma.
Global Pharma Healthcare did not immediately respond to a Reuters request seeking comment on the FDA statement.
The US agency said it was collaborating with the Centers for Disease Control and Prevention (CDC) and state and local health departments to investigate a multistate outbreak involving a rare, extensively drug-resistant bacteria.
It said that as of 31 January, the CDC had identified 55 patients in 12 states with infections linked to the use of Artificial Tears distributed by EzriCare.
"Associated adverse events include hospitalisation, one death with bloodstream infection, and permanent vision loss from eye infections," the FDA said.
EzriCare said in a statement on Wednesday that it had stopped further distribution and sale of the eye drop, and it was not aware of any testing that "definitively links" the bacterial outbreak to the product.
Delsam Pharma did not immediately respond to a request for comment from Reuters.