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The U.S. Food & Drug Administration (FDA) is urging consumers not to purchase or use EzriCare Eyedrops out of fear of contamination. The artificial tears have been linked to a number of serious injuries. Lawsuits related to the use of the eyedrops allege that the product can cause vision loss or even death.
At Bailey Cowan Heckaman PC, our lawyers are currently accepting and litigating EzriCare eye drop cases. We have extensive experience helping those who have been injured by dangerous and defective products such as these artificial tears. If you or a loved one has suffered harm after using EzriCare brand eye drops or artificial tears, contact our office at (888) 367-7160 to schedule a free consultation.
EzriCare LLC is the distributor of a brand of artificial tear eye drops manufactured by Global Pharma Healthcare Private Limited (Global Pharma). Global Pharma is an international pharmaceutical company with a corporate office and factory located in Tamilnadu, India. According to its website, the company manufactures several over-the-counter drugs and ointments.
EzriCare Artificial Tears Lubricant Eye Drops are used by individuals suffering from any number of symptoms. It is generally used to relieve “dry, irritated eyes” such as “dry eye.”
EzriCare Artificial Eye Drops are used:
The over-the-counter ocular lubricant is sold at pharmacies and drug stores across the country. It is also available over the Internet. Eye drops were used in both inpatient and outpatient healthcare facilities, as well as at a patient’s home.
In February 2023, the U.S. Food and Drug Administration (FDA) issued a warning to consumers to not purchase or use EzriCare Artificial Tears over fears of contamination. Distributors of the potentially contaminated artificial tears include Aru Pharma/Ezricare LLC and Delsam Pharma. The recalled artificial tears (carboxymethylcellulose sodium) are sold in 10 mg in 1 mL, ½ fl oz (15 ml) bottles.
Eyedrops manufactured by Global Pharma that have been recalled:
Reports of infection are believed to be related to microbial contamination of the bottles. Regulatory agencies such as the U.S. Centers for Disease Control and Prevention and the FDA believe that Global Pharma’s use of multiple-use containers made them more prone to contamination.
The use of contaminated artificial tears can cause a serious, potentially deadly drug-resistant infection.
Signs of infection include:
The infection can cause devastating health complications such as keratitis, respiratory issues, urinary tract infection, or endophthalmitis. In severe cases, the infection can cause permanent loss of vision or death if the infection enters the bloodstream (sepsis).
EzriCare Eye Drops are a type of preservative-free lubricant, intended to be sterile. However, an outbreak of a rare bacterial strain was linked back to bottles of the artificial tears. Preservative-free tears are usually sold in single-use packaging. The EzriCare Eye Drops were manufactured and distributed in multi-use bottles, making them more prone to contamination.
Samples indicate that the bacteria has been present in the product since at least May 2022. The bacterial strain of Verona Integron-mediated Metallo-β-lactamase (VIM) and Guiana-Extended Spectrum-β-Lactamase (GES)-producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) is extraordinarily rare and can be fatal.
In February 2023, a recall was recommended due to Global Pharma’s failure to follow good manufacturing practices such as not performing adequate microbial testing, formulation issues, and not having tamper-evident packaging.
The first EzriCare consumer class action was filed in February 2023. Our attorneys continue to investigate and litigate claims related to these potentially deadly artificial tears.
May 2022 - January 2023: The CDC in partnership with local health departments collects specimens dated between May 2022 to January 2023 from multiple healthcare facilities after a rare bacterial strain outbreak is discovered. The majority of patients identified with the infection report using EzriCare Artificial Tears.
January 20, 2023: The CDC makes public the ongoing investigation into a “multistate cluster of Pseudomonas aeruginosa infections.” The investigation focuses on the potential link to over-the-counter artificial tears.
January 24, 2023: EzriCare announces that they have been made aware of the CDC’s investigation. The company recommends that individuals should discontinue the use of any portions of the product out of an “abundance of caution.”
February 1, 2023: EzriCare LLC states that it will “stop any further distribution or sale of EzriCare Artificial Tears.”
The CDC issues an official health advisory cautioning consumers to stop using EzriCare artificial tears pending additional guidance. 55 cases are identified across 12 states. The majority of patients report using EzriCare eye drops. One death is linked to the bacterial infection.
February 2, 2023: The FDA issues a warning for consumers not to purchase or use the potentially contaminated product.
EzriCare manufacturer Global Pharma issues a “voluntary nationwide recall” of all unexpired lots of their eye drops sold under the brand names of EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears.
February 21, 2023: The FDA issues an additional warning for consumers to discontinue the use of Delsam Pharma’s Artificial Eye Ointment due to similar concerns over contamination.
February 24, 2023: Voluntary recall issued by Global Pharma for “Batch No. H29 of Artificial Eye Ointment, distributed by Delsam Pharma” due to potential microbial contamination.
March 21, 2023: The CDC provides an updated case count, noting that as of March 14, 2023, they have identified at least 68 patients across 16 states with the dangerous infection linked to the use of artificial tears. Reporting indicates that at least three people have died, eight people have lost their vision and four people have had to have the surgical removal of an eyeball (enucleation).
April 2023: An FDA investigation reveals numerous failures to properly sterilize the facility where EzriCare is created, as well as serious flaws in the facility's "filtration process."
May 2023: The FDA issues a public safety warning regarding the potential dangers of EzriCare.
June 2023: 14 product liability cases regarding EzriCare injuries have been filed across 7 different federal districts, 6 of which are in New Jersey.
September 2023: CVS, Walgreens, and six other companies are warned to cease sales of eye drops that have not been approved by the FDA. CVS and Walgreens have complied and are issuing refunds to consumers. We are still waiting for news on how the other companies have responded.
If you used EzriCare Eye Drops and suffered an adverse reaction, you might be entitled to compensation. Contact our office today to speak directly with an experienced attorney. Call (888) 367-7160 to schedule a free, no-obligation consultation.