Eye drop recall: FDA inspection finds sterilization problems at recalled manufacturer’s facility in India
The manufacturer of eye drops that has been linked to an outbreak of serious bacterial infections in the United States, including at least three deaths, did not follow proper protocol to prevent contamination of its products, according to an inspection report published Friday by the US Food and Drug Administration.
The FDA visited a Global Pharma Healthcare facility in India for an inspection that began in mid-February, 2½ weeks after the company recalled EzriCare Artificial Tears due to possible contamination.
At the time of the recall, there were 55 reports of adverse events, including eye infections, permanent vision loss and at least one death with a bloodstream infection. By the end of last month, 68 infections had been identified in 16 states, according to the US Centers for Disease Control and Prevention. There have been three deaths, eight cases of vision loss and four surgical eye removals reported.
An 11-day inspection of the Global Pharma facility resulted in 11 observations by the FDA, including a “manufacturing process that lacked assurance of product sterility,” specifically for product batches manufactured between December 2020 and April 2022 and shipped to the United States.
The EzriCare Artificial Tears product, which is manufactured by Global Pharma, is part of an outbreak of infections from bacteria called Pseudomonas aeruginosa.
These rare drug-resistant bacteria can spread among people who don’t have symptoms — and to people who haven’t used eye drops, according to the CDC. This type of spread is particularly common in healthcare.
“The bacteria can spread when a patient carrying the bacteria exposes another patient, or when patients touch common objects or when healthcare workers transfer bacteria, which is why infection control, such as hand hygiene, is so important,” the agency told CNN in a email Monday.
Several cases in the current outbreak have been identified in people who carried the bacteria without signs or symptoms of clinical infections, the CDC said. These cases were detected through screenings at stationary health facilities that had clusters of infections.
The particular strain of the bacteria associated with this outbreak had never before been reported in the United States, and related infections have been identified in acute care, long-term care, urgent care, urgent care, and other outpatient settings.
People affected by the outbreak reported using different brands of artificial tears, but EzriCare Artificial Tears was most commonly reported.
The FDA inspection of the Global Pharma facility is part of an ongoing compliance case.
“FDA’s highest priority is to protect public health — this includes working with manufacturers to quickly remove unsafe drugs from shelves when they are identified,” the agency said in an email Monday. “FDA continues to monitor this issue and is working with the Centers for Disease Control and Prevention (CDC) and the companies that are recalling these affected products. We encourage consumers to stop using these products that may be harmful to their health.”