FDA Recalls EzriCare & Delsam Pharma Eye Drops
On February 2, 2023 the U.S. Food & Drug Administration announced a Nationwide recall of EzriCare & Delsam Pharma Artificial Tears eye drops due to potential microbial contamination after 55 reports of adverse events including eye infections, permanent loss of vision, and a death with a bloodstream infection.
Which Eye Drops Are Recalled?
Artificial Tears (carboxymethylcellulose sodium) Lubricant Eye Drops, 10 mg in 1 mL, ½ fl oz (15 ml) bottles. The product is packaged in a bottle with a safety seal and are placed in a carton box:
- Ezricare NDC 79503-0101-15, UPC 3 79503 10115 7;
- Delsam Pharma’s NDC 72570-121-15, UPC -72570-0121-15.
The contaminated over-the-counter eye drops were manufactured in India by Global Pharma Healthcare and sold Nationwide in the U.S. on amazon.com and other websites.
The FDA has cited that the eye drop recall was recommended to Global Pharma based on manufacturing problems including lack of testing and proper controls on the packaging. Furthermore, the FDA has blocked the importation of the contaminated Ezricare and Delsam Pharma eye drops into the United States.
CDC Investigates Multi-State Outbreak of Eye Infections
On January 20, 2023 the U.S. Centers for Disease Control and Prevention (CDC) issued an update into a multi-state investigation into a cluster of bacteria resistant infections linked to the EzriCare Artificial Tears brand of eye drops.
Specifically, Integron-mediated Metallo-β-lactamase (VIM)- and Guiana-Extended Spectrum-β-Lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections are associated with the use of the artificial tears manufactured by Global Pharma Healthcare.
Between May 2022 in January 2023 the CDC along with state and local Health departments have identified at least 55 cases where patients from 12 states have been diagnosed with Pseudomonas aeruginosa, a type of bacteria resistant to most antibiotics.
Pseudomonas bacteria are common in the environment, such as in soil and water. Pseudomonas aeruginosa is usually spread in health care settings, the CDC says, and is increasingly difficult to treat because of antibiotic resistance. It caused more than 32,000 infections in hospitalized patients and about 2,700 deaths in the US in 2017.
Complications From Recalled Eye Drops
As of May 19, 2023, at least four people have died and at least 14 others have been left with permanent vision loss due to the bacterial infections caused by the contaminated EzriCare Artificial Tears eye drops.
More than 80 people developed eye infections, and the CDC has reported four cases of surgically removed eyeballs. Others had respiratory infections or urinary tract infections. One person died when the bacteria entered the patient’s bloodstream.
Many people are probably wondering; How could contaminated eye drops affect the blood, lungs or other areas of the body? According to the CDC, the eye connects to the nasal cavity through tear ducts. Bacteria can move from the nasal cavity into the lungs. Also, bacteria in these parts of the body can seed infections at other sites such as in the blood or wounds
Investigators found the bacteria were not susceptible to any antibiotics routinely tested at public health laboratories. However, a newer antibiotic named cefiderocol did seem to work.
Cases have been reported in California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah and Washington.
Most patients said they’d used EzriCare or Delsam Pharma Artificial Tears branded eye drops before becoming ill.
Eye Drop Lawsuit Filed in New Jersey After Woman Suffers Pseudomonas aeruginosa Bacterial Infection
On Feb. 11, 2023, a New Jersey woman filed a lawsuit against EzriCare, Ezrirx, Aru Pharma, and Walmart for the production and marketing of the contaminated eye drops. The plaintiff contracted a serious bacterial infection from the EzriCare eye drops that spread to her torso, abdomen, and back.
Questions About an EzriCare or Delsam Pharma Eye Drop Infection Lawsuit? Contact a Lawyer.
If you or a loved one developed an eye infection or suffered from any other complications related to the contaminated EzriCare or Delsam Pharma Artificial Tears eye drop products, you may want to speak with the lawyers at Johnson//Becker, PLLC. We are actively pursuing new eye drop recall lawsuits across the country, and you may be entitled to financial compensation.
We offer a Free Case Evaluation. Please contact us using the form below or by calling us at (800) 279-6386.
We would be honored to speak with you and respond promptly to every inquiry we receive.