Federal safety officials have been recalling several brands of eye drops over the last few weeks due concerns about bacterial infections following reports of injuries, blindness and at least one death.
Over 120 million people in America used eye drops or eye wash last year, according to Statista.
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On Feb. 2, Global Pharma Healthcare, which is based in India, said it was voluntarily recalling all lots of its EzriCare and Delsam Pharma brands of Artificial Tears Lubricant Eye Drops due to a possible microbial contamination.
“To date, there are 55 reports of adverse events including eye infections, permanent loss of vision, and a death with a bloodstream infection,” the U.S. Food and Drug Administration said in a filing.
The Centers for Disease Control and Prevention (CDC) alerted the FDA to an investigation of a multi-state outbreak of a drug-resistant strain of Pseudomonas aeruginosa possibly associated with the use of the artificial tears product.
Eight Reports of Vision Loss and One Death
As of March 1, CDC said it had worked with state and local health departments and identified 64 patients in 13 states, including California, Florida, New Mexico and Utah. Thirty-seven patients were linked to four healthcare facility clusters.
One person has died and there have been 8 reports of vision loss, the CDC said. Most patients reported using artificial tears.
Customers have been advised to immediately stop using the drops.
On Feb. 24, Global Pharma recalled one batch of a product distributed by Delsam Pharma,"Artificial Eye Ointment," due to possible microbial contamination that could cause infections leading to blindness.
The product was distributed nationwide. Global Pharma Healthcare said it had not received any reports of adverse events related to the ointment.
The company said it was notifying the brand owner and importer of the product, Delsam Pharma, about the recall, and asking wholesalers, retailers, and customers who have the recalled ointment to stop using it and discard it safely and appropriately.
On March 1, Apotex recalled six lots of its own brand of glaucoma drops, called "Brimonidine Tartrate Ophthalmic Solution, 0.15%," which is for patients with open-angle glaucoma or ocular hypertension.
Concerns About Sterility
“This recall is being initiated out of an abundance of caution due to cracks that have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles,” the Weston, Fla.-based company said in a statement. "There is a possibility the broken cap may impact sterility and if so, the possibility of adverse events."
And on March 3, Pharmedica USA LLC voluntarily recalled two lots of Purely Soothing, 15% MSM Drops due to concerns about sterility.
The eye drop is used as an anti-inflammatory aimed to assist with symptoms of ocular irritation or swelling.
Using contaminated eye drops can result in the risk of eye infections that could result in blindness, the FDA said. To date, Pharmedica USA has not received any reports of adverse events.
The company said customers should immediately stop using the product and return it to the place of purchase.
Wholesalers and retailers were asked to stop distributing the eye drops and immediately return them to Pharmedica or confirm that the product has been disposed of with proper verification.
