EzriCare and Delsam Artificial Tears Recall
Global Pharma Healthcare issued a February 2023 recall for EzriCare Artificial Tears, Delsam Pharma Artificial Tears and Delsam Pharma Artificial Eye Ointment because of potential bacterial contamination. The CDC reported some people lost their vision and four people died.
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Which EzriCare and Delsam Eye Drops Were Recalled?
On Feb. 2, 2023, Global Pharma Healthcare recalled EzriCare Artificial Tears and Delsam Pharma Artificial Tears. These EzriCare eye drops were sold online, mainly through Walmart or Amazon. At one point, EzriCare Artificial Tears were one of the top 10 products sold on Amazon for dry eye relief, according to CBS News.
- 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
On Feb. 24, 2023, Global Healthcare also recalled its Delsam Pharma Artificial Eye Ointment (mineral oil 15%, white petrolatum 83%, 3.5 grams / 1/8 oz.). The recalled batch number is H29, NDC 72570-122-35, UPC 3 72570 12235 3.
The Centers for Disease Control and Prevention and the U.S. Food and Drug Administration have warned people to stop using these products because of the risk of serious eye infections.
Why Were EzriCare Artificial Tears Recalled?
Global Pharma Healthcare recalled EzriCare Artificial Tears Lubricant Eye Drops because the CDC and FDA have linked the product to a multistate outbreak of infections caused by Pseudomonas aeruginosa bacterium.
The eye drop manufacturer also recalled Delsam Pharma Artificial Tears and Delsam Pharma Artificial Eye Ointment after the FDA recommended the recall for potential microbial contamination. In addition, eye ointment packages were leaking and could be otherwise compromised.
“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,” Global Pharma told CBS News.
According to the latest May 2023 EzriCare eye drop recall update from the CDC, 81 patients in 18 states have been infected by a bacterium called Verona Integron-mediated Metallo-β-lactamase (VIM) and Guiana-Extended Spectrum-β-Lactamase (GES)-producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA)
Risks of EzriCare Artificial Tears
The biggest risk of using EzriCare Artificial Tears is becoming infected with VIM-GES-CRPA. When the CDC tested opened bottles of EzriCare Artificial Tears, the products tested positive for VIM-GES-CRPA.
This is a very rare strain of Pseudomonas aeruginosa that hasn’t been seen in the U.S. before. It led to eye infections that caused vision loss in 14 people and four deaths, according to the CDC’s May 15, 2023, update. The infection can also spread past the eye and into other parts of the body.
Other EzriCare Artificial Tears side effects not related to infections include eye pain, blurry vision and allergic reactions.
FDA Response to Artificial Tears Recall
In partnership with the CDC, the FDA continues to investigate the bacterial outbreak linked to EzriCare Artificial Tears. The agencies are working together to test unopened bottles of EzriCare eye drops to see if the products were contaminated during manufacturing. As of March 21, 2023, there have been no updates on testing results. In the meantime, the FDA has warned people not to use recalled products.
Global Pharma Healthcare didn’t comply with current good marketing practices, or CGMP, according to the FDA. The eye drop maker didn’t properly test for bacteria, didn’t use an adequate preservative and didn’t have good manufacturing controls for tamper-evident packaging.
The agency has since placed Global Pharma on import alert. The import alert prevents the India-based manufacturer’s products from entering the U.S.
What Should I Do If I Used Recalled EzriCare Artificial Tears?
If you used recalled EzriCare Artificial Tears, stop using the product right away. The CDC doesn’t recommend bacterial testing for people with no symptoms. So, if you don’t have any symptoms of infection, you don’t have to take action.
But people who used EzriCare or Delsam Pharma Artificial Tears and have infection symptoms should contact their medical providers and seek medical care right away, according to the CDC.
- Blurry vision
- Discharge from the eye that’s yellow, green or clear
- Eye or eyelid redness
- Eye pain or discomfort
- Feeling that there is something in your eye (foreign body sensation)
- Increased light sensitivity
Can I File an EzriCare Lawsuit?
If you or a loved one suffered an eye infection or vision loss after using EzriCare or Delsam Pharma Artificial Tears, you may be able to file an EzriCare or Delsam lawsuit for compensation. After the recall, people began filing injury lawsuits against Global Pharma, EzriCare, Aru Pharma, Walmart and others.
Carolyn Ward sued EzriCare, Aru Pharma and Walmart after she suffered an eye infection. Even after she underwent antibiotic and steroid treatments, the infection spread to her torso, back and abdomen.
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