The Food and Drug Administration (FDA) has expanded its warning related to over-the-counter (OTC) eye care products manufactured by Global Pharma Healthcare Private Limited.
The Agency is now including Delsam Pharma’s Artificial Eye Ointment on its list of “do not purchase” products because of possible bacterial contamination. Earlier this month, Global Pharma Healthcare had announced a nationwide recall of its artificial tear lubricant eye drops distributed by EzriCare, LLC and Delsam Pharma.
The recall was issued after the Centers for Disease Control and Prevention (CDC) announced its investigation into a multistate cluster of Verona Integron-mediated Metallo-β-lactamase- and Guiana-Extended Spectrum-β-Lactamase- producing carbapenem-resistant Pseudomonas aeruginosa infections linked to these products.
Adverse events related to the use of these products have included hospitalization, permanent vision loss from eye infections, and even a death due to a bloodstream infection. Recent CDC analysis confirms the link between EzriCare Artificial Tears and 56 infections across 12 states.
According to the FDA, Global Pharma Healthcare has agreed to recall Delsam Pharma’s Artificial Eye Ointment.
US Food and Drug Administration. FDA warns consumers not to purchase or use Delsam Pharma’s Artificial Eye Ointment due to potential bacterial contamination. News release. February 22, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-ezricare-artificial-tears-due-potential-contamination.