Death and Infections From Eye Drops Prompt CDC and FDA Investigation, Recall

The manufacturer of an over-the-counter lubricating eye drop has issued a recall due to a number of reports of Pseudomonas aeruginosa infection associated with its use, according to a US Food and Drug Administration (FDA) release.¹ 

The FDA is encouraging all patients who experienced signs or symptoms of an eye infection after using EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears (both Global Pharma) to seek immediate medical attention. EzriCare use has been epidemiologically linked with 55 adverse events in 12 states which include hospitalization, 5 cases of permanent vision loss, and 1 death, the report shows.¹  

The recall notification suggests that the manufacturer violated a number of current good manufacturing practice regulations, “including lack of appropriate microbial testing, formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use bottles, without an adequate preservative), and lack of proper controls concerning tamper-evident packaging.”¹ 

Pseudomonas aeruginosa is often nosocomially acquired — frequently affecting the blood, lungs, or other body parts. The bacteria demonstrates high antibiotic resistance, limiting treatment options among those infected. Frequent hand washing and good hygiene practices may limit the spread of germs responsible for these infections, but their antimicrobial resistance continues to present a challenge for health care staff.² Global Pharma’s products are currently prohibited from entering the US due to poor manufacturing practices and failure to adequately respond to records requests.¹