EzriCare & Delsam Artificial Tears Class Action
Many people use artificial tears to help with dryness, irritation, and fatigue of the eyes. The recent filing of a class action lawsuit suggests that certain brands of artificial tears may not currently be safe to use.
EzriCare & Delsam Artificial Tears
Consumers who rely on EzriCare and Delsam Artificial Tears recently learned of a voluntary nationwide recall of these products. Approximately one week later, a class action lawsuit against the company that manufactures these brands, Global Pharma Healthcare, was filed in Kentucky.
According to the U.S. Food & Drug Administration, these artificial tears products may be contaminated with bacteria. People who become infected with these bacteria may discover that they are lethally ill.
The nearly 30-page complaint states that EzriCare and Delsam Artificial Tears products may be contaminated with a particular bacteria strain that is resistant to known drugs. According to the class action lawsuit, this contamination arose as a result of insufficient microbial testing at the site of manufacture, problems with the formulation process, and a lack of packaging controls that are designed to prevent tampering.
Known as Pseudomonas aeruginosa, the bacteria can be responsible for ailments of the eyes, skin, and lungs. So far, this contaminant has been discovered in two batches of artificial tears that were distributed across a dozen states.
The class action complaint against EzriCare and Delsam Artificial Tears notes that so far 55 people have been diagnosed as suffering from illnesses that are directly related to infection with Pseudomonas aeruginosa. Three of these people now have permanent vision loss while a fourth passed away after suffering an infection of the bloodstream.
The FDA Intervenes
On February 2, 2023, the FDA and Global Pharma Healthcare issued a notice of voluntary nationwide recall for EzriCare and Delsam Artificial Tears based on potential microbial contamination.
According to the announcement, consumers are warned to immediately stop the use of these products. Moreover, healthcare providers are being counseled to not offer these products to patients.
Also in the announcement was an “import alert” that prevents Global Pharma from importing these products into the U.S. The FDA enacted this additional measure because of a finding that Global Pharma provided an “inadequate response to records request” when they were initially informed of the issue. The citation also mentions that the company does not comply with the requirements outlined in current good manufacturing practices.
The CDC Outlines the Dangers
The class action lawsuit complaint asserts that Global Pharma knew or should have known that these products were contaminated. Nonetheless, the company failed to make the data public, and they continued to publicly insist that the artificial tears were safe to use.
The contaminated products first appeared on the market in May 2022. Since then, the eye drops have appeared in Wisconsin, Washington, Utah, Texas, Nevada, New York, New Mexico, New Jersey, Florida, Connecticut, Colorado, and California.
According to the CDC, the bacteria involved in the contamination are “incredibly drug-resistant and dangerous.” Testing conducted on open bottles of EzriCare Artificial Tears found evidence of the presence of the bacteria in multiple lot numbers in a pair of states.
The CDC contacted Global Pharma to inform them of multiple reports of adverse events resulting from the use of EzriCare and Delsam Artificial Tears products. The company confirmed receipt of the notification concerning the CDC investigation, and officials stated that they would immediately cease the sale and distribution of these products even though there was no proof linking the adverse events and their products.
Are You a Class Action Member?
The class action will represent all individuals who bought EzriCare and Delsam Artificial Tears dating from May 1, 2022, to the present. Full refunds are intended to be offered to all those who purchased these products for personal use in the U.S. or its territories.
If you believe that you should be a member of this lawsuit, please contact the Clark Law Firm P.C. at 1-877-841-8855. If you prefer to chat online, simply visit this link.