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On February 2, 2023, FDA Med Watch announced the recall of Global Pharma Healthcare of all lots within the expiry of their Artificial Tears Lubricant Eye Drops, distributed by /EzriCare, LLC- and Delsam Pharma, due to possible contamination.
The Centers for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state 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.
To date, there are 55 reports of adverse events including eye infections, permanent loss of vision, and death with a bloodstream infection.
Risk Statement: The use of contaminated artificial tears can result in the risk of eye infections that could result in blindness.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: Artificial Tears (carboxymethylcellulose sodium) 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.
RECOMMENDATIONS:
Consumers, patients, and health professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
click on the red button "Read Recall" below for more information about this recall
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This recall notice was shared by FDA MedWatch and updated by Anita Johnson-Brown
Photo: FDA