FDA Widens Advisory on Eye Products After Patients Blinded, Hospitalized
On Feb. 21, the U.S. Food and Drug Administration's (FDA) advisory on artificial tear products was expanded to include additional products manufactured by Global Pharma Healthcare Private Ltd. The advisory now urges consumers and health care professionals not to use EzriCare Artificial Tears and Delsam Pharma's Artificial Tears and Artificial Eye Ointment, which are intended to be sterile, over concerns about potential bacterial contamination. The artificial tear products were first recalled by the manufacturer due to what the FDA called violations of its current good manufacturing practice, citing issues with drug formulation, packaging, and microbial testing. In early February, the Centers for Disease Control and Prevention warned against using EzriCare or Delsam Pharma's artificial tears products amid an investigation of around 56 cases of Pseudomanas aeruginosa bacteria in 12 states, including one death and five instances of vision loss.
Read more on The Hill.