The US Food and Drug Administration (FDA) has warned against using Indian-made eye drops that have been linked to the outbreak of drug-resistant bacteria causing adverse events. in at least 55 patients in the United States, including infections, blindness, and one death
The agency said on Thursday that Artificial Tears eye drops made by India’s Global Pharma Healthcare Pvt Ltd. have possible bacterial contamination and that the company has violated current good manufacturing practices.
Global Pharma Healthcare, based in the southern city of Chennai, said on Wednesday it had issued a voluntary consumer-level recall of current lots of the eye drops, which were distributed in the United States by EzriCare LLC and Delsam Pharma.
INDIAN COUGH SYRUP MANUFACTURER LINKED TO DEATHS OF 19 CHILDREN IN UZBEKISTAN STOPS PRODUCTION
Global Pharma Healthcare did not immediately respond to a Reuters request for comment on the FDA statement.
EzriCare said in a statement Wednesday that it had stopped distribution and sale of the eye drops, and was not aware of any evidence that “definitely links” the bacterial outbreak to the product.
The Food and Drug Administration has warned against using eye drops from an Indian manufacturer, which have been linked to serious bacterial infections.
(REUTERS/Andrew Kelly/File photo)
The company removed the products as requested, a Delsam Pharma spokesperson said, adding that the products had a security seal on top and were not associated with customer cases.
An Indian government source told Reuters on Friday that federal and state drug regulators have sent a team to a manufacturing plant near Chennai under contract to Global Pharma Healthcare.
“It is a contract manufacturing facility that supplies through others to the US market,” the source said, adding that this specific drug was not sold in India.
INDIA TEST OF COUGH SYRUP LINKED TO DEATHS OF CHILDREN IN WEST AFRICA
The incident comes after the deaths of at least 70 children in The Gambia and 19 children in Uzbekistan last year were linked to Indian-made cough syrups, damaging the country’s image as the “pharmacy of the world.” “.
The FDA said it was collaborating with the Centers for Disease Control and Prevention (CDC) and state and local health departments to investigate a multi-state outbreak involving a rare and widely drug-resistant bacterium.
He said that as of January 31, the CDC had identified 55 patients in 12 states with infections related to the use of artificial tears distributed by EzriCare, he said.
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“Associated adverse events include hospitalization, one death from bloodstream infection, and permanent loss of vision from eye infections,” the FDA said.
