The Federal Drug Administration (FDA) on Wednesday expanded their prior recall of eye drops to include another imported product as a drug-resistant bacteria outbreak continues to plague the nation.
The FDA warned consumers and health care providers in early February to stop using EzriCare Artificial Tears after the drops were linked to drug-resistant infections in 55 people across 12 states. Five of the infections resulted in permanent vision loss and at least one had resulted in death due to the presence of the bacteria Pseudomonas aeruginosa.
The FDA warned of another imported eye product that could be contaminated with bacteria, in the wake of an outbreak earlier this year of highly drug-resistant bacteria that hospitalized and blinded some patients. https://t.co/VmVun1kASE
— CBS News (@CBSNews) February 23, 2023
“In addition to Artificial Tears products, FDA is also now warning consumers and health care professionals not to purchase or use Delsam Pharma’s Artificial Eye Ointment due to potential bacterial contamination. This is an over-the-counter product, manufactured by Global Pharma Healthcare Private Limited, intended to be sterile,” a report from the FDA stated.
The manufacturer, Global Pharma Healthcare Private Limited, is the same company that produces EzriCare Artificial Tears and is based in India, CBS News reported. The FDA faulted the company for multiple violations and has banned its items from being imported into the United States, the outlet reported. (RELATED: Company Recalls 145,000 Cans Of Baby Formula Over Potentially Dangerous Bacteria)
The Centers for Disease Control (CDC) announced Feb. 21, they were working in coordination with the FDA as well as state and local governments to investigate the outbreak which now has affected 13 states and 58 patients. The CDC also noted that the particular strain of Pseudomonas aeruginosa present in patients affected by the outbreak had never been reported in the United States previously.
Of the 58 patients infected, 16 have been hospitalized, five have suffered permanent vision loss, one has had to have an eye surgically removed, and another died after the infection entered their bloodstream, CBS News reported.
A spokesman for the CDC told the outlet, “We are actively gathering more information about long term patient outcomes, particularly for patients with eye infections.