RECALL: EYE DROPS LIKE ARTIFICIAL TEARS
RECALL Although patients reported using multiple brands of eye drop artificial tears, only two have been recalled to date. They are EzriCare and Delsam Pharma. As of March 1, 2023, there have been 64 patients in 16 states (CA, CO, CT, FL, IL, NC, NJ, NM, NY, NV, PA, SD, TX, UT, WA, WI). Three have died and there have been 8 reports of vision loss and 4 have had surgical removal of their eyeball. Most patients reported using multiple brands. Thirty-seven patients were linked to four healthcare facility clusters. The investigation to date has identified artificial tears as a common exposure for many patients.
There is now a multistate outbreak associated with multiple types of infections including eye infections which has resulted in the recall of eye drops. This is a rare extensively drug-resistant strain that has never been reported in the United States prior to this outbreak. There has also been a collaboration with the CDC, FDA, and state and local health departments.
Are you using RECALLED EYEDROPS? Do you have blurry vision; eye pain or discomfort; increased sensitivity to light; feeling something is in your eye; redness of eye or eyelid; clear/yellow/or green eye discharge?
Two Recalled Products EzriCare Artificial Tears, a preservative-free, over-the-counter product packaged in multidose bottles, was the brand most commonly reported. This was the only common artificial tears product identified across the four healthcare facility clusters. Laboratory testing by CDC identified the presence of VIM-GES-CRPA in opened EzriCare bottles from multiple lots; these bottles were collected from patients with and without eye infections and from two states. VIM-GES-CRPA recovered from opened products matches the outbreak strain. Testing of unopened bottles of EzriCare Artificial Tears is ongoing to assist in evaluating whether contamination may have occurred during manufacturing.
Delsam Pharma’s Artificial Tears is the second one.
Patient Information You should stop using EzriCare or Delsam Pharma’s Artificial Tears pending additional information and guidance from CDC and FDA. If you were advised to use EzriCare or Delsam Pharma’s Artificial Tears by your healthcare provider, you should follow up with your healthcare provider for recommendations about alternative treatment options.
If you have used EzriCare or Delsam Pharma’s artificial tears and have signs or symptoms of an eye infection, seek medical care immediately. At this time, there is no recommendation for testing patients who have used this product and who are not experiencing any signs or symptoms of infection.
Medically this is a multistate outbreak of an extensively drug-resistant strain of Pseudomonas aeruginosa. The outbreak strain is carbapenem-resistant Pseudomonas aeruginosa with Verona integron-mediated metallo-β-lactamase and Guiana extended-spectrum-β-lactamase (VIM-GES-CRPA). FDA warns consumers not to purchase or use EzriCare Artificial Tears due to potential contamination
Global Pharma Healthcare Issues Voluntary Nationwide Recall of Delsam Pharma Artificial Eye Ointment Due to Possible Microbial Contamination