Eye Drops Sold at Walmart and Amazon Recalled After 55 Reports of Infection, FDA Warns
The FDA and the CDC are conducting an ongoing investigation.
Eye drops are a medicine cabinet necessity for many of us—and with spring fast approaching, they're a must-have if you suffer from hay fever. You might also rely on them in the winter when your eyes are irritated or dry due to cold weather.
You'll want to double-check your supply, however, as the U.S. Food and Drug Administration (FDA) has just issued a recall for two brands of eye drops. The drops in question, which are sold at both Amazon and Walmart, have led to 55 reports of infection, loss of vision, and even death.
Read on to find out which brands are affected, and what to do if you have them at home.
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Two brands of eye drops are part of the recall.
The FDA and the Centers for Disease Control and Prevention (CDC) are investigating an "extensively drug-resistant" strain of the bacteria Pseudomonas aeruginosa, according to a Feb. 1 Health Alert Network Health Advisory from the CDC.
As of Jan. 31, the strain was detected in 55 patients from 12 U.S. states: California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah, Washington, and Wisconsin. According to a CDC Outbreak and Patient Notification, the "common exposure" appears to be artificial tears eye drops—patients reported using 10 different brands, the most common being EzriCare Artificial Tears.
In light of the investigation, Global Pharma Healthcare issued a voluntary recall of its EzriCare, LLC and Delsam Pharma Artificial Tears, the FDA announced on Feb. 2. Global Pharma is "fully cooperating" with investigators, the company told CBS News. "Thus far we have not determined whether our manufacturing facility is the source of the contamination. Nevertheless, out of an abundance of caution, we are recalling the products at issue," the company said.
Serious infections, vision loss, and one death were reported.
After using the eye drops, patients reported eye inflammation, respiratory infections, urinary tract infections, and sepsis, the CDC said. In some cases, these conditions resulted in more serious outcomes, including permanent vision loss, hospitalization, and one death related to a bloodstream infection.
The specific strain of Pseudomonas aeruginosa bacteria is called Verona Integron-mediated Metallo-β-lactamase (VIM) and Guiana-Extended Spectrum-β-Lactamase (GES), which is shortened to VIM-GES-CRPA. The strain has never been reported in the U.S. until now, according to the CDC.
So far, bacterial contamination has only been detected in opened bottles of EzriCare from two states. The CDC said contamination could have occurred while the drops were being used, or during the manufacturing process. The agency is currently testing unopened bottles of EzriCare Artificial Tears to confirm whether this could have happened during manufacturing.
Also on Feb. 2, the FDA warned customers not to purchase either EzriCare or Delsam Pharma artificial tears, explaining that Global Pharma Healthcare Private Limited, based in India, was in violation of the regulatory agency's current good manufacturing practice (CGMP) due to a "lack of appropriate microbial testing, formulation issues…and lack of proper controls concerning tamper-evident packaging. The company was placed on import alert, according to the FDA, meaning these products cannot enter the U.S.
If you have these eye drops, stop using them immediately.
According to the CDC, the bacteria Pseudomonas aeruginosa is a germ found in soil and water, and it is commonly spread in healthcare settings. It can infect different parts of your body, including your eyes and lungs. Making things more complicated, these infections are becoming more difficult to treat due to antibiotic resistance, which means the germs don't respond to the medication trying to kill them.
Both the CDC and the FDA say you should stop using any recalled eye drops—and that if your healthcare provider recommended the brands, to contact them for an alternative.
The CDC urges you to be proactive if you're displaying signs of an infection. "Patients who used EzriCare Artificial Tears and who have signs or symptoms of an eye infection, such as discharge from the eye, eye pain or discomfort, redness of the eye or eyelid, feeling of something in the eye, increased sensitivity to light, or blurry vision, should seek timely medical care," the Health Advisory states.
However, if you used these products and don't have symptoms, the CDC is not currently recommending that you see your healthcare provider.
Here's how to identify recalled products.
Per the FDA, the recall applies to all lots of unexpired EzriCare and Delsam Pharma artificial tears. The artificial tears eye drops, which are used to prevent irritation or to relieve dryness or discomfort, had a safety seal and were sold in carton boxes over the counter.
Artificial tears distributed by EzriCare have a National Drug Code (NDC) of 79503-0101-15 and a universal product code (UPC) of 3-79503-10115-7. Those distributed by Delsam Pharma have an NDC of 72570-121-15 and a UPC of 72570-0121-15. UPCs are printed underneath the barcode on the bottom of the box, while NDCs are printed in the top right corner on the front of the box.
The artificial tears were sold online in the U.S., the recall announcement states. They were "obtained through Amazon and Walmart," a CDC spokesperson confirmed to CBS News, as well as during inpatient and outpatient visits. The EzriCare drops were also one of the best-selling dry eye care relief products on Amazon last year, the outlet reported.
Global Pharma Healthcare is notifying both distributors about the issue, requesting that wholesalers, retailers, and customers stop using the products. You can report adverse reactions to the FDA's MedWatch Adverse Event Reporting program online, by mail, or by fax.