Why Are Eye Drop Products Being Recalled?
On February 2, the U.S. Food and Drug Administration (FDA) issued a warning to consumers that eye drops sold under the brand name EzriCare Artificial Tears Lubricant Eye Drops and Delsam Pharma Artificial Tears Lubricant Eye Drops were being recalled due to potential bacterial contamination. The FDA warning and voluntary recall was expanded to include Delsam Artificial Eye ointment on February 21.
The FDA cited potential bacterial contamination from Pseudomonas aeruginosa. Pseudomonas refers to a type of bacteria commonly found in soil and water. The CDC stated that the strain Pseudomonas aeruginosa commonly causes disease in humans. Pseudomonas aeruginosa typically develops in healthcare settings due to contaminated equipment and is usually treated with antibiotics. However, the CDC also reported this bacteria could be resistant to medication and can cause severe disease, blindness and death.
The FDA also said the artificial tears eye drop recall comes due to the failure of the company to adequately test its product for bacterial contamination without adequate preservatives, a violation of the Good Manufacturing Practice regulations that require sterile products.
This month, the FDA announced two more recall notices for specific eyedrops distributed by Pharmedica and Apotex. There is no indication that these latest recalls are associated with the other recalled eyedrops products.
What Consumers Need to Know
Regarding the EzriCare and Delsam eye drops and ointment, the CDC confirmed 66 cases of related illness in patients. Patients who experienced illness reported sensitivity to light and severe eye infections. Eight patients also reported partial vision loss and there has been one death when the infection turned into sepsis. Cases were reported in 13 different states- California, Colorado, Connecticut, Florida, Illinois, New Jersey, New Mexico, New York, Nevada, Texas, Utah, Washington, and Wisconsin.
Consumers should immediately stop using any EzriCare Artificial Tears, Delsam Pharma Artificial Tears and Delsam Artificial Eye Ointment. Using contaminated artificial tears or ointment can lead to eye infections or blindness.
According to the CDC, consumers who have used the products should watch for symptoms of an eye infection such as yellow, green, or clear discharge from the eye, eye pain or discomfort, redness of the eye or eyelid or blurry vision. If consumers notice any of these symptoms, they should contact a healthcare provider immediately.
What Eye Drop Products Are Part of the Recalls?
All unexpired artificial tears products sold under the brand names EzriCare Artificial Tears Lubricant Eye Drops and Delsam Pharma Artificial Tears Lubricant eye drops are being recalled. Since the initial warning, the recall has expanded to include Delsam Artificial Eye ointment.
Although the EzriCare and Delsam Pharma recall does not list locations where the products were sold, illnesses occurred between May 2022 and January 2023. It’s reported that Walmart and Amazon sold the contaminated products online.
The artificial tears products are packaged in a bottle with a safety seal and placed in a box. The boxes are labeled with the following codes:
- For EzriCare Artificial tears (blue box): NDC 79503-0101-15 and UPC 3, 79503 10115 7
- For Delsam Pharma (white box): NDC 72570-121-15 and UPC 72570-0121-15
The Delsam Artificial Eye ointment is packaged in a tube and placed in a box. The boxes are labeled with the following code (white box): NCD 72570-122-35.
In the most recent recalls, Pharmedica issued a voluntary recall of Purely Soothing 15% MSM Drops due to non-sterility. Pharmedica advises customers to immediately stop using the product and return it to the place of purchase. The Apotex voluntary recall is for six (6) lots of Brimonidine Tartrate Ophthalmic Solution, 0.15%. 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 broken cap may impact sterility and, if so, the possibility of adverse events.
What Should Consumers of Recalled Eye Drops Do Now?
As the investigation continues, consumers should report adverse events from any of these recalled products to the FDA. They should also consult with their healthcare provider if they are experiencing any eye issues, and speak to them about other dry eye treatments.
Anyone who has suffered an injury from using the recalled eye drop products may want to consult a personal injury attorney for legal guidance. The first lawsuit against EzriCare was filed in Florida. Theresa Phillips experienced itching and discomfort a week after purchasing the EzriCare artificial tears lubricant. Phillips had to undergo surgery to help with some of her eye problems and is still experiencing symptoms.
Those affected by recalled contaminated eye drops could suffer a range of damages. A personal injury lawyer can help to determine if you have an eye drops injury lawsuit and should fight for compensation for medical bills and treatments for bacterial eye infections, lost wages, pain and suffering, and other damages.