FDA expands recall of potentially contaminated eye products amid outbreak
The Food and Drug Administration warned Wednesday 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, the FDA says, 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 were already recalled earlier this year. The FDA had faulted the company for multiple violations and banned imports into the United States of its items.
That had followed a nationwide health alert issued by the Centers for Disease Control and Prevention over an outbreak of a "rare, extensively drug-resistant" Pseudomonas aeruginosa bacteria. The strain had never before been seen in the U.S.
As of Tuesday, the CDC says 58 patients have been identified. Since the alert earlier this month, a 13th state, Illinois, has been added to the list of jurisdictions with cases.
At least 16 patients have been hospitalized from their infections so far, 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 about long term patient outcomes, particularly for patients with eye infections," the spokesperson said.
Investigators had turned up opened bottles of the EzriCare eye drops contaminated with the bacteria at the homes of multiple patients in the outbreak. However, three unopened EzriCare bottles gathered by health authorities did not have signs of contamination. Additional bottles are being tested.
Most cases linked to the outbreak involved eye drops purchased online before the recall. However, one reported buying EzriCare at a Costco warehouse.
Like the EzriCare products earlier, the Delsam Pharma Artificial Eye Ointment is still listed for sale on several websites including Amazon. It ranks among the top 50 best-selling "dry eye relief" products on the site.
It is not clear what prompted the FDA to expand its warning. A spokesperson for the regulator declined to share additional details on the "ongoing matter."
The company, which is based in India, was subjected to a late-night inspection earlier this month, Indian news outlet NDTV reported, and has since suspended production of the Delsam Pharma and EzriCare products.
A spokesperson for Global Pharma Healthcare did not immediately return a request for comment.