FDA Widens Warning for Contaminated Eye Products

Stop buying or using Delsam Pharma’s Artificial Eye Ointment, the U.S. Food and Drug Administration warned Wednesday.

The over-the-counter product is made by the same company that makes eye drops that were recalled earlier this year amid an outbreak of a highly drug-resistant bacteria that has hospitalized and blinded patients.

Those products, which include EzriCare and Delsam Pharma artificial tears, are manufactured and exported by the Indian company Global Pharma Healthcare Private Limited.

The FDA faulted the company for multiple violations, and has banned imports of the company’s items into the United States, CBS News reported.

It’s not clear what prompted the most recent warning, CBS News said.

At least 16 patients had been hospitalized earlier for an outbreak of the “rare, extensively drug-resistant” Pseudomonas aeruginosa bacteria, a strain that had not been seen in the United States before. The U.S. Centers for Disease Control and Prevention has issued a nationwide health alert about the bacteria.

The outbreak involved patients in 12 states. Five were permanently blinded. One had to have an eyeball surgically removed, CBS News reported. A patient in Washington state died when the infection spread to the bloodstream.

Federal investigators found opened EzriCare eye drops contaminated with the bacteria at the homes of multiple patients. However, three unopened bottles did not have signs of contamination. Investigators are testing more bottles.

Most patients bought the drops online, though one reported buying it in a Costco warehouse, CBS News reported.

The Delsam Pharma Artificial Eye Ointment is still listed for sale on several websites, including Amazon, CBS News reported.

More information

The U.S. National Library of Medicine has more on the bacteria involved in the recent outbreak.

SOURCE: CBS News