The Food and Drug Administration recommended expanding a recall to include additional eye drop products due to possible contamination.
The FDA now encourages the public to immediately stop using Delsam Pharma’s Artificial Eye Ointment due to potential bacterial contamination after a previous recall of ErziCare Artificial Tears. This comes after officials said 58 eye infections, including one that was fatal, were potentially tied to the products.
Officials said on Tuesday the number of cases being investigated is up to 58.
Global Pharma Healthcare Private Limited makes both products and initiated a recall of the products.
Officials said isolates detected VIM‐GES‐CRPA, which are highly antimicrobial drug-resistant pathogens that are uncommon in the United States, according to the National Institutes of Health. The Centers for Disease Control and Prevention said some infections caused permanent vision loss.
The CDC said that most patients used artificial tears products before infection, with EzriCare Artificial Tears being the most common. The CDC said in January that testing of unopened products is ongoing.
“CDC recommends that clinicians and patients immediately discontinue the use of EzriCare Artificial Tears until the epidemiological investigation and laboratory analyses are complete,” the CDC said.
