The Food and Drug Administration (FDA) has expanded its warning related to over-the-counter (OTC) eye care products from Global Pharma Healthcare Private Limited.
Due to possible bacterial contamination, the agency is now adding Delsam Pharma’s artificial eye ointment to its list of products that cannot be purchased. Earlier this month, Global Pharma Healthcare announced a nationwide recall of its artificial tear eye drops sold 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 carbapenem-resistant Verona Integron-mediated metallo-β-lactamase and Guyana extended spectrum β-lactamase-producing agents Pseudomonas aeruginosa Infections associated with these products.
Adverse events associated with the use of these products have included hospitalization, permanent vision loss due to eye infections, and even death due to a bloodstream infection. A recent CDC analysis confirms the link between EzriCare artificial tears and 56 infections in 12 states.
According to the FDA, Global Pharma Healthcare has agreed to recall Delsam Pharma’s artificial eye ointment.
reference
US Food and Drug Administration. The FDA warns consumers not to purchase or use Delsam Pharma’s artificial eye ointment due to possible bacterial contamination. Press 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.
This article originally appeared on MPR
