Global Pharma Healthcare is issuing a recall of its Artificial Tears Lubricant Eye Drops that were distributed by EzriCare and Delsam Pharma due to possible contamination, the US Food and Drug Administration said Thursday.
The drops were sold online across the US in multidose bottles. Consumers should stop using them and report any adverse reactions to the FDA.
The US Centers for Disease Control and Prevention is investigating 55 reports of infections, one fatal, in 12 states that may be linked with the products.
The CDC says it received reports of infections of the cornea, intraocular fluids, respiratory tract and urinary tract, as well as sepsis. Some of the cases involved permanent vision loss or hospitalization, and one person died.
Most people with infections reported using at least one of more than 10 brands of artificial tears, the agency says, and the majority of these patients reported using EzriCare’s product. These eye drops are preservative-free, meaning they don’t have ingredients to prevent bacterial growth.
Testing of open EzriCare bottles identified Pseudomonas aeruginosa bacteria that are resistant to a broad array of antibiotics. The bacteria could have come from contamination either during use or during the manufacturing process, the CDC says. Testing of unopened bottles is ongoing.
New Jersey-based EzriCare said in a statement that after learning about the investigation January 20, it “immediately took action to stop any further distribution or sale of EzriCare Artificial Tears. To the greatest extent possible, we have been contacting customers to advise them against continued use of the product.”
Pseudomonas bacteria are common in the environment, such as in soil and water. Pseudomonas aeruginosa is usually spread in health care settings, the CDC says, and is increasingly difficult to treat because of antibiotic resistance. It caused more than 32,000 infections in hospitalized patients and about 2,700 deaths in the US in 2017.