The Centers for Disease Control and Prevention is collaborating with the U.S. Food and Drug Administration and local health departments to investigate an outbreak of keratitis, conjunctivitis and systemic infection attributed to EzriCare Artificial Tears, an OTC product.  By the end of January, 55 cases were identified in 12 states from May 2020 through January 2023.   

The contaminant is a multidrug-resistant Pseudomonas aeruginosa. The pathogen has been isolated from bronchial washes, corneas, urine, blood and rectal swabs from patients.  The same organism was isolated and characterized from the eye-product and from patients.  The pathogen, unique to the U.S. is a carbapenem-resistant Pseudomonas expressing a metallo-beta-lactamase. The reason for this is that the product was manufactured by Global Pharma Healthcare of Chennai, India. This represents an examle of the lack of supervision exercised by the FDA over foreign biopharmaceutical plants. If not a proverbial 'black eye" for the FDA it certainly is a red eye and bilateral!

 Based on epidemiologic investigations and laboratory assay, the FDA issued an urgent caution to cease using the implicated product while epidemiologic investigations are in progress.

Pseudomanas aeruginosa is frequently implicated in high chick mortality due to omphalitis attributed to contamination of hatchery environments.