Contaminated eye drops are likely responsible for 55 patients in 12 states of America identified with VIM-GES-CRPA, a rare strain of extensively drug-resistant Pseudomonas aeruginosa bacteria. Of those patients, by 31 January 2023, one had died, five had suffered permanent vision loss and others had developed eye infections.
The story presents a timely reminder that patients should be advised to only buy medications recommended by a healthcare professional, and to only buy from reliable sources.
The Artificial Tears Lubricant Eye Drops believed to be responsible were distributed nation-wide in the United States over the internet by EzriCare and Delsam Pharma.
Marketed as EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears, they have been voluntarily recalled due to possible contamination by manufacturer Global Pharma Health.
The story presents a timely reminder that patients should be advised to only buy medications recommended by a healthcare professional, and to only buy from reliable sources
Centers for Disease Control and Prevention (CDCP) advised patients and healthcare providers to immediately stop the use of EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears pending additional information and guidance from CDC and FDA.1
Multiple Issues Noted
While patients presenting with adverse events reported over 10 different brands of artificial tears and some patients used multiple brands CDCP stated that EzriCare Artificial Tears “was the brand most commonly reported”.1
VIM-GES-CRPA, that matched the outbreak strain, was identified in opened EzriCare bottles collected from patients with and without eye infections and from two states.1
A statement released from the United States Food and Drug Administration (FDA) highlighted multiple issues with Global Pharma Health.2
“Global Pharma initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears. FDA recommended this recall due to the company’s current good manufacturing practice (CGMP) violations, 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.
Additionally the statement read, “FDA also placed Global Pharma Healthcare Private Limited on import alert for providing an inadequate response to a records request and for not complying with CGMP requirements. The import alert prevents these products from entering the United States.”