NEW DELHI - The U.S. Food and Drug Administration (FDA) has warned against using an eye drop 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 United States 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.
Global Pharma Healthcare, based in the southern city of Chennai, said on Wednesday 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.
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.
The company has removed the products as requested, a Delsam Pharma spokesperson said, adding that the products had a safety seal top and were not associated with customer cases.
An Indian government source told Reuters on Friday that the federal and state drug regulators have sent a team to a manufacturing plant near Chennai contracted by Global Pharma Healthcare.
"It is a contract manufacturing plant supplying through others to the U.S. market," the source said, adding that this specific drug was not sold in India.
The incident comes after the deaths of at least 70 children in Gambia and 19 children in Uzbekistan last year were linked to India-made cough syrups, which has dented 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 multistate outbreak involving a rare, extensively drug-resistant bacteria.
It said that as of Jan. 31, the CDC had identified 55 patients in 12 states with infections linked to the use of Artificial Tears distributed by EzriCare, it said.
"Associated adverse events include hospitalization, one death with bloodstream infection, and permanent vision loss from eye infections," the FDA said.
(Reporting by Shivam Patel and Krishna N Das in New Delhi, Editing by William Maclean, Frances Kerry and Anil D'Silva)