The Food and Drug Administration (FDA) on Tuesday widened an advisory on artificial tear products to include additional ones manufactured by Global Pharma Healthcare Private Limited over concerns of a potential bacterial contamination that could result in blindness or death.
The FDA warning now urges consumers and health care professionals not to use EzriCare Artificial Tears, Delsam Pharma’s Artificial Tears and Delsam Pharma’s Artificial Eye Ointment, which are intended to be sterile.
The manufacturer first recalled the artificial tears at the recommendation of the FDA due to what the agency says were violations of its current good manufacturing practice.
Among the issues noted by the FDA were drug formulation issues, concerns about packaging and lack of appropriate microbial testing.
The Centers for Disease Control and Prevention (CDC) earlier this month warned against using the EzriCare or Delsam Pharma’s Artificial Tears products as it investigated what it says is a potentially related string of some 56 Pseudomonas aeruginosa bacterial cases.
The cases span 12 states and include five reports of vision loss and one death, according to the CDC’s latest update.
