Global Pharma Healthcare is voluntarily recalling all lots within expiry of Artificial Tears Lubricant Eye Drops to the consumer level due to possible contamination.
The recalled lots of Artificial Tears Lubricant Eye Drops, 10mg in 1mL, ½ fl oz (15mL) bottles were distributed nationwide by EzriCare, LLC (NDC 79503-0101-15; UPC 79503 10115 7) and Delsam Pharma (NDC 72570-121-15; UPC 72570-0121-15). Artificial Tears Lubricant Eye Drops are used as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun.
A recent communication from the Centers for Disease Control and Prevention (CDC) alerted to a multistate cluster of Verona Integron-mediated Metallo-β-lactamase (VIM)- and Guiana-Extended Spectrum-β-Lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare.
The Company has stated that the use of contaminated artificial tears may result in the risk of eye infections leading to permanent vision loss. To date, there have been 55 reports of adverse events resulting in ocular infections, permanent loss of vision, and 1 death from bloodstream infection.
Adverse reactions or quality problems should be reported to the Food and Drug Administration’s MedWatch program.
Global Pharma Healthcare issues voluntary nationwide recall of Artificial Tears Lubricant Eye Drops due to possible contamination. News release. Global Pharma Healthcare. February 2, 2023. Accessed February 3, 2023. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/global-pharma-healthcare-issues-voluntary-nationwide-recall-artificial-tears-lubricant-eye-drops-due