The US Food and Drug Administration (FDA) has warned against the use of eye drops made in India that has been linked to the outbreak of a drug-resistant bacteria leading to adverse events in at least 55 patients in the US including infections , blindness and one death.
The agency said on Thursday that Artificial Tears eye drops manufactured by India’s Global Pharma Healthcare Pvt Ltd. has potential bacterial contamination and that the company violated current good manufacturing practices.
Global Pharma Healthcare, based in the southern city of Chennai, said on Wednesday it had issued a voluntary consumer-wide recall of unexpired batches of the eye drops, distributed in the United States by EzriCare LLC and Delsam Pharma.
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Global Pharma Healthcare did not immediately respond to a request from Reuters for comment on the FDA statement.
EzriCare said in a statement Wednesday that it has stopped further distribution and sale of the eye drops and is unaware of any tests that “definitively link” the bacterial outbreak to the product.
The Food and Drug Administration has warned against the use of eye drops from an Indian manufacturer, which have been linked to serious bacterial infections.
(REUTERS/Andrew Kelly/File Photos)
The company removed the products as requested, a Delsam Pharma spokesman said, adding that the products had a superior safety seal 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 facility near Chennai contracted by Global Pharma Healthcare.
“This is a contract manufacturing facility that supplies through others to the US market,” the source said, adding that this specific drug has not been sold in India.
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The incident comes after the deaths of at least 70 children in The Gambia and 19 children in Uzbekistan last year were linked to cough syrups made in India, which dented the country’s image as the ‘pharmacy of the world’.
The FDA said it is working 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 largely drug-resistant bacteria.
It said that as of Jan. 31, the CDC had identified 55 patients in 12 states with infections related to the use of artificial tears distributed by EzriCare.
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“Associated adverse events include hospitalization, one death from a bloodstream infection, and permanent vision loss due to eye infections,” the FDA said.
