February 06, 2023 : Global Pharma Healthcare voluntarily recalls all lots within the expiry of their Artificial Tears Lubricant Eye Drops, given out by EzriCare, LLC- and Delsam Pharma, to the customer level, owing to possible impurity. The Centers for Disease Control and Prevention (CDC) warned FDA to an examination of a multi-state cluster of Verona Integron-mediated Metallo-β-lactamase (VIM)- and Guiana-Extended Spectrum-β-Lactamase (GES)- creating carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections possibly associated with the benefit of the artificial tears manufactured by Global Pharma Healthcare. To date, there are 55 reports of negative events, including eye infections, permanent loss of eyesight, and death with a bloodstream illness.
Risk Statement: Using infected artificial tears can increase the risk of eye diseases that could lead in blindness.
Artificial Tears (carboxymethylcellulose sodium) Lubricant Eye Drops, 10 mg in 1 mL, ½ fl oz (15 ml) bottle, are utilized as a protectant against further irritation or to reduce dryness of the eye for the temporary relief of distress due to minor offenses of the eye, or to vulnerability to wind or sun. The drops is packaged in a bottle with a safety seal and is put in a carton box Ezricare NDC 79503-0101-15, UPC 3 79503 10115 7; Delsam Pharma’s NDC 72570-121-15, UPC -72570-0121-15. The product was dispersed Nationwide in the USA over the Internet.
Global Pharma Healthcare is advising the distributors of this product, Aru Pharma Inc. and Delsam Pharma, and is asking that wholesalers, retailers, and consumers who have the recalled product should cease use.