Global Pharma Healthcare did not immediately respond to a request seeking comment on the FDA statement.
The US agency said it is working with the Centers for Disease Control and Prevention (CDC) and state and local health departments to investigate a multistate outbreak linked to a rare, widely drug-resistant bacteria.
It said that as of January 31, the CDC had identified 55 patients in 12 states with infections linked to the use of artificial tears distributed by Ezricare.
“Related adverse events included one hospitalization, one death from a bloodstream infection, and one death from an eye infection leading to permanent vision loss,” the FDA said.