The Food and Drug Administration on Wednesday 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.
Americans should stop using Delsam Pharma’s artificial eye ointment, says the FDA, an over-the-counter product manufactured by Global Pharma Healthcare Private Limited. The company has agreed to recall the product.
It’s the same manufacturer behind the EzriCare and Delsam Pharma artificial tears products that already were remembered earlier this year. The FDA had accused the company of multiple violations and banned the importation of its items into the United States.
That followed a nationwide health alert issued by the Centers for Disease Control and Prevention about a outbreak of a “rare, highly resistant” Pseudomonas aeruginosa bacteria. The species had never been seen in the US before
As of Tuesday, the CDC says 58 patients have been identified. Since the warning earlier this month, a 13th state, Illinois, has been added to the list of jurisdictions with cases.
So far, at least 16 patients have been hospitalized for their infections, a CDC spokesperson told CBS News in a statement. Five were permanently blinded and one had to have an eyeball surgically removed. A patient died in Washington state after the infection spread to their bloodstream.
“We are actively gathering more information on long-term patient outcomes, particularly for patients with eye infections,” the spokesperson said.
Investigators had found opened bottles of EzriCare eye drops contaminated with the bacteria at the homes of several patients during the outbreak. However, three unopened EzriCare bottles collected by health authorities showed no signs of contamination. Additional bottles are tested.
Most of the cases linked to the outbreak involved eye drops purchased online before the recall. However, one reported purchasing EzriCare from a Costco warehouse.
Like the EzriCare products before, the Delsam Pharma artificial eye ointment is still for sale on various websites, including Amazon. It is in the top 50 best-selling “dry eye relief” products on the site.
It’s not clear what prompted the FDA to expand its warning. A spokesperson for the regulator declined to share additional details about the “ongoing case”.
The India-based company was inspected late at night earlier this month, Indian news outlet NDTV reported, and has since suspended production of its Delsam Pharma and EzriCare products.
A spokesperson for Global Pharma Healthcare did not immediately return a request for comment.
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