CDC Expands Recall of OTC Artificial Tears
After reports of additional infections, the Centers for Disease Control and Prevention (CDC) has expanded its recall of OTC eye drops to include Delsam Pharma’s Artificial Tears products. The call for immediate discontinuation comes a month after the agency recommended immediate discontinuation of the use of EzriCare Artificial Tears after linking various infections with the drops.
“Patients should stop using EzriCare or Delsam Pharma’s Artificial Tears pending additional information and guidance from CDC and FDA,” the CDC posted as a notification on its website. “If patients were advised to use EzriCare or Delsam Pharma’s Artificial Tears by their healthcare provider, they should follow up with their healthcare provider for recommendations about alternative treatment options. Patients who have used EzriCare or Delsam Pharma’s artificial tears and who have signs or symptoms of an eye infection should seek medical care immediately. At this time, there is no recommendation for testing of patients who have used this product and who are not experiencing any signs or symptoms of infection.”
The CDC is collaborating with the FDA and state and local health departments to investigate a multistate outbreak of an extensively drug-resistant strain of Pseudomonas aeruginosa. The outbreak is associated with multiple types of infections, including eye infections. The investigation to date has identified artificial tears as a common exposure for many patients.
As of February 21, 2023, the CDC has identified 58 patients in 13 states (CA, CO, CT, FL, IL, NJ, NM, NY, NV, TX, UT, WA, WI) with VIM-GES-CRPA, a rare strain of extensively drug-resistant P. aeruginosa. Thirty-five patients were linked to four healthcare facility clusters. One person has died and there have been 5 reports of vision loss. Dates of specimen collection were from May 2022 to January 2023.
Isolates have been identified from clinical cultures of sputum or bronchial wash (13), cornea (12), urine (9), other nonsterile sources (4), and blood (2), and from rectal swabs (25) collected for surveillance; some patients had specimens collected from more than one anatomic site.
Patients reported over 10 different brands of artificial tears and some patients used multiple brands. 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.
FDA encourages health care professionals and patients to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program. Consumers may also report adverse reactions by contacting FDA’s Consumer Complaint Coordinators.