On Friday, the FDA released an inspection report that claimed EzriCare Artificial Tears did not follow the correct protocol to prevent product contamination.
According to the report, the producer has been linked to a series of bacterial infections, which have claimed the lives of three people.
In mid-February, 2.5 weeks after the product was recalled, the FDA inspected a Global Pharma Healthcare facility in India for 11 days due to possible contamination.
During the recall, 55 incidents of eye infections, permanent vision loss, and at least one death from a bloodstream infection had been reported.
According to the FDA, an 11-day inspection resulted in 11 observations, including “a manufacturing process that did not ensure product sterility” for batches shipped to the US between December 2020 and April 2022.
EzriCare Artificial Tears is currently part of an outbreak of Pseudomonas aeruginosa, a drug-resistant bacteria.
There has never been a report of this particular strain of bacteria in the US. Patients affected by this outbreak reported using different brands of artificial tears, but EzriCare Artificial Tears were the most frequently used.
An FDA compliance investigation is currently underway at Global Pharma Healthcare.
“The FDA’s highest priority is protecting public health — this includes working with manufacturers to quickly remove unsafe drugs from shelves when they are identified,” the agency said on Monday. “The FDA continues to monitor this issue and is working with the Centers for Disease Control and Prevention (CDC) and the companies recalling these affected products. We urge consumers to stop using these products, which may be harmful to their health.”
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