Artificial Tears Lubricant Eye Drops
EZRICARE & DELSAM PHARMA ARE BEING RECALLED DUE TO POTENTIAL BACTERIAL CONTAMINATION
On February 2nd, 2023, Global Pharma Healthcare made an announcement through the FDA that their brands of artificial tears, EzriCare & Delsam Pharma, are being voluntarily recalled by the manufacturing company. EzriCare and Delsam Pharma’s artificial tear solutions have been historically used as an artificial eye lubricant to assist in relieving symptoms of dry, itchy, and irritated eyes caused by a wide range of symptoms, such as wind and sun irritation, allergies, and general eye discomfort. Currently, the Centers for Disease Control and Prevention is investigating 55 reports of infections that have likely stemmed from using these products across 12 different states. According to the announcement made on February 2nd, “The Centers for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of Verona Integron-mediated Metallo-β-lactamase (VIM)- and Guiana-Extended Spectrum-β- Lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES- CRPA) infections possibly manufactured by Global Pharma Healthcare” (U.S. Food and Drug Administration, 2023.)
The contamination of these products has led to multiple reports of eye infections, urinary tract infections, permanent vision loss, respiratory tract infections, and one reported death due to sepsis.
EzriCare’s products are advertised as “preservative free”, making these tear solutions a habitable environment for bacteria growth, and testing of opened EzriCare bottles confirmed the presence of Pseudomonas Aeruginosa bacteria, which happen to be resistant to a broad spectrum of antibiotics currently in use to fight bacterial infections. Pseudomonas Aeruginosa is typically contracted in a healthcare setting such as a hospital or a doctor’s office, and these infections can be quite serious or even fatal due to the resistant nature of these bacteria which have become increasingly prevalent and more difficult to treat with current antibiotics available. In 2017 alone, Pseudomonas Aeruginosa strains caused more than 32,000 infections in the United States and caused an estimated 2,700 deaths in the United States in hospitalized patients.
EzriCare products have been distributed nationwide through online sales, and at this time it is unknown how far-reaching the potential bacterial contamination of these products has become. Global Pharma Healthcare, the manufacturer of the potentially contaminated EzriCare and Delsam Pharma products, has notified the distributors of these products and is currently requesting that any wholesalers, retailers, and customers who have the recalled products should immediately stop use and discontinue their sales. Consumers of these products who have experienced adverse reactions such as infections of the eye, or any infections involving Pseudomonas Aeruginosa are encouraged to report these occurrences to the FDA's MedWatch Adverse Event Reporting program as soon as possible to aid in the investigation of the outbreak.
