Dry eye sufferers across the U.S. were put at risk when using dry eye solutions made by both EzriCare and Delsam Pharma, resulting in a product recall. A rare strain of bacteria found in the recalled eye drops has led to dozens of infections, cases of vision loss, surgical removal of the eyes, and even death.
The CDC reports about 70 infections spread across 16 states. The recalled product was nearly all imported from India.
What products were recalled?
- EzriCare Artificial Tears Lubricant Eye Drops (carboxymethylcellulose sodium) 10 mg in 1 mL, ½ fl. oz. (15 ml) bottle. NDC 79503-0101-15, UPC 3 79503 10115 7
- Delsam Pharma Artificial Tears and Lubricant Eye Drops (carboxymethylcellulose sodium) 10 mg in 1 mL, ½ fl. oz. (15 ml) bottle. NDC 72570-121-15, UPC 3 72570 12115 8
- Delsam Pharma Artificial Eye Ointment, Batch H29 – NDC 72570-122-35, UPC 3 72570 12235 3
Check the NDC, UPC, and batch numbers at the bottom of the package to see if your product is affected by this recall.
How are the eye drops contaminated?
Global Pharma issued its product recall because some of its Artificial Tears Lubricant Eye Drops were shown to have microbial contamination. The specific type of bacteria found in the product has been strongly drug-resistant, which has led to problems such as eye loss and death because the bacteria infects the bloodstream.
The bacteria known as Pseudomonas aeruginosa has been around for quite some time, but the strain has evolved to a version never seen before in the U.S.; Verona Integron-mediated Metallo-β-lactamase – and Guiana-Extended Spectrum-β-Lactamase. This strain is resistant to nearly all available treatments.
How did the eye drops become contaminated?
The contamination of Global Pharma artificial tears products was believed to have occurred during the manufacturing process in India. The FDA placed Global Pharma on an import alert because the company did not follow the manufacturing protocols advised by the FDA. This is a direct violation of current good manufacturing practices. Additional concerns have been raised regarding supply chain procedures.
How many people have been permanently injured?
The most common symptom for use of the contaminated products are eye infections. Some of those infections have led to serious injuries, which have so far included:
- Enucleation (having eyes surgically removed) – 4 people
- Blindness – 8 people
- Death – 3 people
What are the symptoms of an eye infection?
If you have used this or another dry eye product, you can detect multiple symptoms associated with eye infections, including:
- Chronic redness of the eyes
- Persistent itching
- Eye irritation/pain/discomfort
- Swelling of the eyes and eyelids
- Discharge (yellow, green, or clear)
- Watery eyes
- Blurry vision
- Light sensitivity
- Foreign body sensations
- Flaking eyelids
I use artificial tears. What should I do?
If you’re like me and use artificial tears, news of this contamination is likely quite terrifying. Here are some recommended precautions when using synthetic tears products:
- Wash hands before applying and/or touching eyes.
- Do not touch the tip of the eye dropper.
- Inspect the packaging to ensure it is pristine and there are no signs of cracking, contamination or leaking.
- Read the product labels prior to use.
- Properly store the product and throw it away if it has been left open for too long (bacteria can start to grow).
- If using preservative-free drops, use single-use bottles to prevent contamination from use and opening/closing.
- Use preservative-containing drops (many contain benzalkonium chloride, which can be an eye irritant to some users.)
- Consult with your ophthalmologist and/or optometrist regarding your prospective use of artificial tears.
- See an ophthalmologist or optometrist upon any indication of eye infection.
What states have been affected by the recall?
Since the initial announcement, the CDC has 16 states where new infection cases have taken place:
- California
- Colorado
- Connecticut
- Florida
- Illinois
- Nevada
- New Jersey
- New Mexico
- New York
- North Carolina
- Pennsylvania
- South Dakota
- Texas
- Utah
- Washington
- Wisconsin
Consumers need not suffer infections, blindness, or death due to unsanitary conditions at manufacturing plants. If you have been injured by these recalled products, you may be eligible for compensation. The experienced product liability lawyers at Allen & Allen are here to help. For a free case evaluation, call today at 866-388-1307.
