The manufacturer of eye drops linked to an outbreak of serious bacterial infections in the US, including at least three deaths, did not follow proper protocol to prevent contamination of its products, according to an inspection report published by the FDA
The FDA visited a Global Pharma Healthcare facility in India for an inspection that started in mid-February, two and a half weeks after the company had voluntarily recalled the EzriCare Artificial Tears product due to possible contamination. At the time of the recall, there were already 55 reports of adverse events including eye infections, permanent loss of vision and at least one death with a bloodstream infection.
EzriCare Artificial Tears product, which is manufactured by Global Pharma Healthcare, is part of an outbreak of a rare and drug-resistant bacteria called Pseudomonas aeruginosa. The particular strain of the bacteria associated with this outbreak had never before been reported in the US. Patients affected by the outbreak reported using different brands of artificial tears, but EzriCare Artificial Tears was most commonly reported.
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