FDA turns up sterility issues at eye drop facility linked to deaths, vision loss
The U.S. Food and Drug Administration (FDA) has found a drug-resistant bacteria at an eye drop manufacturing facility linked to severe infections and a few deaths.
The findings come after the FDA announced the recall of two eye drop brands, EzriCare and Delsam Pharma artificial tears. Earlier, Global Pharma Healthcare also issued a recall of its eye drops after the drops were linked to 55 reports of adverse events, including eye infections, permanent loss of vision and one death with a bloodstream infection. However, the impact has since expanded to three deaths.
The FDA inspected Global Pharma’s facility in Rockville, Maryland, from February 20 through March 2, finding issues with sterilization.
The FDA noted of the facility during an inspection, “You used a manufacturing process that lacked assurance of product sterility.”
According to the agency, the facility used this deficient manufacturing process to manufacture eye drops between December 2020 and April 2022. The agency also noted that “the equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for intended use.” In addition, the agency found issues with cleaning and disinfecting.
The FDA collaborated with the Centers for Disease Control and Prevention (CDC) in the eye drop investigations of the multistate outbreak of an extensively drug-resistant strain of Pseudomonas aeruginosa. This is the first time the outbreak strain has been reported in the United States.
“At this time, CDC and FDA recommend clinicians and patients stop using EzriCare or Delsam Pharma’s Artificial Tears products pending additional guidance from CDC and FDA,” the CDC said at the end of March.
As of mid-March, the outbreak was reported in 68 patients in 16 states, with three people who died and eight who experienced vision loss. Most of the patients reported using artificial tears, according to the CDC.
Amy joined TriMed Media as a Senior Writer for HealthExec after covering home care for three years. When not writing about all things healthcare, she fulfills her lifelong dream of becoming a pirate by sailing in regattas and enjoying rum. Fun fact: she sailed 333 miles across Lake Michigan in the Chicago Yacht Club "Race to Mackinac."