Do not purchase or use Delsam Pharma’s Artificial Eye Ointment, the FDA warns.
The announcement released Wednesday adds to a previous warning issued earlier this month for EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination. All three products are manufactured by the same company, Global Pharma Healthcare, based in Tamilnadu, India.
The FDA has faulted the company for multiple violations, including “lack of appropriate microbial testing” and “lack of proper controls concerning tamper-evident packaging,” and has banned imports to the United States.
The updated warning from the FDA did not give additional information about the over-the-counter eye ointment beyond potential bacterial contamination.
On Feb. 1, the CDC issued an alert about an outbreak of a drug-resistant strain of bacteria, Pseudomonas aeruginosa, linked to artificial tear products. To date, 58 patients across 13 states have been identified, and the most commonly reported artificial tear brand was EzriCare Artificial Tears. Five patients had permanent vision loss, and one patient died.
FDA: “FDA warns consumers not to purchase or use EzriCare Artificial Tears due to potential contamination.”
CDC: “Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa Associated with Artificial Tears.”