FDA Broadens Warning on Potentially Contaminated Eye Products

Feb. 22, 2023 — Do not purchase or use Delsam Pharma’s Artificial Eye Ointment, the FDA warns. 

The announcement released Wednesday adds to a previous warning issued earlier this month for EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination. All three products are manufactured by the same company, Global Pharma Healthcare, based in Tamilnadu, India.

The FDA has faulted the company for multiple violations, including “lack of appropriate microbial testing” and “lack of proper controls concerning tamper-evident packaging,” and has banned imports to the United States.

The updated warning from the FDA did not give additional information about the over-the-counter eye ointment beyond potential bacterial contamination. 

On Feb. 1, the CDC issued an alert about an outbreak of a drug-resistant strain of bacteria, Pseudomonas aeruginosa, linked to artificial tear products. To date, 58 patients across 13 states have been identified, and the most commonly reported artificial tear brand was EzriCare Artificial Tears. Five patients had permanent vision loss, and one patient died.

Anyone who has used any of these three products should immediately stop using them and look for signs of infection, including discharge in the eye, eye discomfort, redness, and blurry vision, according to the CDC. If someone has any of these symptoms, they should seek prompt medical care. “At this time, CDC does not recommend testing of patients who have used this product and who are not experiencing any signs or symptoms of infection,” said the agency in a statement.

Thomas Steinemann, MD, clinical spokesperson for the American Academy of Ophthalmology and professor of ophthalmology at MetroHealth Medical Center in Cleveland, noted that while bottles of EzriCare Artificial Tears, Delsam Pharma’s Artificial Tears, and Delsam Pharma’s Artificial Eye Ointment should be discarded, generally eye drops are safe to use. “Millions of Americans use eye drops, and I don’t think people should be concerned,” he says, “but there is always room for improvement in how we use our drops.”

Before using eye drops, always wash your hands first, Steinemann advises. When removing the cap from the bottle, avoid touching the dropper tip to prevent transferring any bacteria from your hand. Also, do not touch the bottle to your eyes, face or nose. When finished, recap the dropper tip. If you use eye drops regularly, pay close attention to product expiration dates. “Once you open an eyedrop [bottle], you want to use it up generally in a month or so,” Steinemann says.

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