Artificial Tears: The Recall Saga

Author: First Sight
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On February 2, 2023, Global Pharma Healthcare recalled two artificial tear products. This came about after EzriCare and Delsam Artificial Tears—over-the-counter eye drops for dry eye relief—were linked to severe side effects.

On February 24, the pharmaceutical company also recalled its Delsam eye ointment for similar reasons.
 

What Really Happened?

The recall came after the FDA and CDC linked EzriCare with an outbreak of eye infections in several states. The other two products were recalled after the FDA cited them for the risk of microbial contamination.

Some of the Delsam ointment packages were also found leaking, which was already a risk factor. The source of the contamination remains unknown, according to the pharmaceutical giant.
 

What Are the Risks of Using EzriCare Artificial Tears?

The main risk of this brand of artificial tears is the bacterium Pseudomonas aeruginosa, also known as VIM-GES-CRPA, found in open medication bottles. This bacterium strain has not been seen in the U.S. before. It is also a very rare form of it. The bacterium is even more dangerous because it can get past the eye and affect other body parts.

According to the latest report on March 21, 2023, the bacteria had caused three deaths, and eight people lost their vision. The artificial tears have been noted for their side effects; even before this saga happened, users reported allergic reactions, blurry vision, and eye pain.
 

What Does the FDA Say About EzriCare Artificial Tears?

The FDA is working with the CDC in an interagency effort to test unopened bottles of the drug to ascertain when the contamination happened. There have yet to be any testing results as of March 21, but the FDA is still warning people not to use the recalled products.

However, the FDA reported that Global Pharma Healthcare was not compliant with good CGMP or marketing practices. They neither used a good preservative nor tested for bacteria, and their manufacturing controls for tamper-evident packaging were less than ideal.
 

What Are the Symptoms of Using the Recalled EzriCare Artificial Tears?

 

• Eyelid or eye redness

• Feeling of sand or a foreign body in the eye

• Blurry vision

• Eye discomfort or pain

• Yellow or green discharge from the eye

• Increased sensitivity to light
  
   

What Should You Do When You Have Dry Eyes?

Usually, artificial tears that you can get over the counter never require a doctor’s intervention or recommendation. You could just get a bottle and use it whenever you have dry eyes. In the face of the saga, it may be prudent to ask your eye doctor about relief from your dry eye. They may be more informed about which artificial tears are good for you.
 

When Should You See a Doctor for Dry Eyes?

You may need to see your doctor if you notice that you need to use artificial tears more often than prescribed. Also, if you have any side effects or reactions that the doctor or the manufacturer did not warn about, see a doctor immediately. 

For more on the recall saga of artificial tears, visit First Sight Eye Care at our office in St. Petersburg, Florida. Call (727) 592-2000 to book an appointment today.