The contaminated deadly and blindness-causing eyedrops that were recalled earlier this year were made in India at a factory not inspected by the FDA, according to a new report.
Scientists are concerned that the once rare treatment-resistant bacteria found in the eyedrops can spread person-to-person and poses a risk of establishing itself as a recurrent problem in the United States, The New York Times reported.
In January, EzriCare and Delsam Pharma artificial tears and ointment products were recalled after being linked to the bacterium P. aeruginosa. The bacteria have caused at least 68 infections, including three deaths and at least eight cases of blindness. The eyedrops were imported to the U.S. from India, and many of the cases occurred after the bacteria spread person-to-person at a long-term care facility in Connecticut, according to the Times, which cited FDA and CDC lead investigator Maroya Walters, PhD. Walters said the cases that caused death or blindness were traced to the EzriCare artificial tears product.
“It’s very hard to get rid of,” University of North Carolina infectious disease specialist David van Duin, MD, PhD, told the Times, noting that the bacteria clings to sink drains, water faucets, and other moist places.
The FDA said it had halted the import of the recalled products and has since visited the plant in India where they were made, which is owned by Global Pharma Healthcare. In a citation to the company dated March 2, the FDA listed nearly a dozen problems, such as dirty equipment and the absence of safety procedures and tests.
The New York Times: “Drug-Resistant Bacteria Tied to Eyedrops Can Spread Person to Person.”
CDC: “Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa Associated with Artificial Tears.”
FDA: “Inspection Document Addressed to Global Pharma Healthcare Pvt. Ltd. With Issue Date March 2, 2023.”
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