On February 2, 2023, the FDA issued a statement warning consumers and health care providers to stop using Delsam Pharma’s Artificial Tears and EzriCare Artificial Tears due to potential bacterial contamination. The FDA warned that using contaminated artificial tears increases the risk of eye infections that could result in blindness or even death.
These over-the-counter products, manufactured by Global Pharma Healthcare Private Limited, should be sterile. However, a Centers for Disease Control and Prevention (CDC) study found an antibiotic resistant bacteria called Pseudomonas aeruginosa in the artificial tears. Pseudomonas aeruginosa is resistant to carbapenem; an antibiotic used to treat complicated bacterial infections. These complicated infections related to carbapenem-resistant Pseudomonas aeruginosa are known in the medical community as CRPA.
On February 21, 2023, the FDA again issued a statement warning that a second product, Delsam Pharma’s Artificial Eye Ointment, should also not be used due to potential contamination. All three of the products have been voluntarily recalled by the manufacturer, Global Pharma Healthcare.
Anyone who has used one of the products and has developed symptoms of an eye infection should seek medical care immediately. Eye infections related to CRPA can cause pain and vision loss. In addition, CRPA infections do not have many treatment options. Therefore, it is important to contact your doctor as soon as possible if there is any sign of a problem. Symptoms of infection can include redness, pain, swelling, itching, pain or change in vision.
Eye infections caused by CRPA may result in the following:
- Pain or vision loss
- Other infections
- Death
Eye drops that may be contaminated with CRPA are labeled with the following product codes:
- Delsam Pharma Artificial Tears NDC 72570-121-15, UPC 3 72570 12115 8
- Delsam Pharma Artificial Eye Ointment NDC 72570-122-35, UPC 3 72570 12235 3
- EzriCare Artificial Tears NDC 79503-0101-15, UPC 3 79503 10115 7
You may qualify to file a claim if you meet the following criteria:
- You purchased and used Delsam or EzriCare Artificial Tears Lubricant Eye Drops or Ointment
- You have proof of purchase or still have the product
- You have experienced vision loss or treatment-resistant infection since using the product
- You have received medical treatment for your vision problems or infection
If you or a loved one have experienced vision issues after using one of these products, it is important to seek treatment immediately. An attorney may also be able to help. The attorneys at Lacy Katzen LLP have been helping people injured by defective products for over 72 years. Please contact Jacqueline M. Thomas for a free consultation.
