A new report from the FDA alleges that Global Pharma Healthcare, manufacturer of the recalled EzriCare Artificial Tears Lubricant Eye Drops, did not follow the proper protocol to prevent product contamination at its production facilities, according to an April 3 report from CNN.
The recalled drops have been linked to the rare bacteria pseudomonas aeruginosa in 68 patients across 16 states, leading to three deaths, four eye removals and eight cases of vision loss.
The FDA visited Global Pharma's India-based plant in mid-February, 2 1/2 weeks after the recall. An 11-day inspection resulted in 11 observations, including a "manufacturing process that lacked assurance of product sterility," according to the report.
The lack of sterilization specifically impacted products manufactured between December 2020 and April 2022 that were shipped to the U.S.
Pseudomonas can spread among patients without symptoms, and it can spread among people who have not used the eye drops via touch.
The particular strain of bacteria associated with the outbreak has never been seen before in the U.S., according to the report.
People impacted by the outbreak have reported using different brands of artificial tears, but EzriCare was mostly commonly reported.