February 22, 2023 – FDA warns: Do not buy or use Delsam Pharma’s artificial eye ointment.
The announcement The warning issued Wednesday complements an earlier warning issued earlier this month for EzriCare artificial tears or Delsam Pharma artificial tears over possible bacterial contamination. All three products are manufactured by the identical company, Global Pharma Healthcare based in Tamilnadu, India.
The FDA accused the corporate of various violations, including “lack of microbiological testing” and “lack of controls regarding tamper-evident packaging,” and imposed an import ban into the United States.
The FDA's updated warning didn't contain any additional information concerning the over-the-counter eye ointment aside from possible bacterial contamination.
On February 1, the CDC issued a warning about an outbreak of a drug-resistant strain of bacteria. Pseudomonas aeruginosa, related to artificial tear products. 58 patients Cases involving artificial tears were identified in 13 states. The mostly cited brand of artificial tears was EzriCare Artificial Tears. Five patients suffered everlasting vision loss and one patient died.
According to the CDC, anyone who has used any of those three products should stop use immediately and look ahead to signs of infection, including discharge from the attention, eye discomfort, redness, and blurred vision. If someone has any of those symptoms, they need to seek immediate medical attention. “At this time, CDC does not recommend testing in patients who have used this product and who do not have signs or symptoms of infection,” the agency said in an announcement.
Thomas Steinemann, MD, clinical spokesperson for the American Academy of Ophthalmology and professor of ophthalmology at MetroHealth Medical Center in Cleveland, identified that while bottles of EzriCare artificial tears, Delsam Pharma artificial tears and Delsam Pharma artificial eye ointment must be thrown away, eye drops typically are secure. “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 the use of our drops.”
Before using eye drops, at all times wash your hands first, advises Steinemann. When you remove the cap from the bottle, avoid touching the dropper tip to forestall bacteria from being transferred out of your hand. Also, don't touch the bottle to your eyes, face or nose. When you're finished, replace the cap on the dropper tip. If you utilize eye drops frequently, pay close attention to the product's expiration date. “As soon as you open an eye drop bottle, [bottle]you generally want to use it up in about a month,” says Steinemann.