EzriCare Artifical Tears – Contamination Can Cause Blindness
This is an information piece. No one should stop medical treatment based on this information herein. Instead, consult qualified healthcare providers, which we are not.
Ketterer, Browne, and Associates, LLC often deals with the intersection of healthcare and law. KBA has been following the Centers For Disease Control and Prevention (“CDC”) work related to EzriCare. Earlier this month, we took a brief look at the controversy surrounding Global Pharma’s EzriCare artificial tear products.
Ezri Artificial Tears
This product is a drug per FDA classification. The artificial tears, which are made of carboxymethylcellulose sodium, lubricate the eyes. The drops comes as 10 mg in a 1 mL, ½ fl oz (15 ml) bottle. They protect against irritation and relieve dryness due to minor irritations of the eye, or to exposure to wind or sun.
EzriCare Artificial Tears comes in a bottle with a safety seal. They come in a carton box Ezricare NDC 79503-0101-15, UPC 3 79503 10115 7; Delsam Pharma’s NDC 72570-121-15, UPC 3 72570 12115 8. The company distributed this product accorss the U.S. over the Internet.
EzriCare Artificial Tears Contamination
EzriCare products came under scrutiny after the Centers For Disease Control identified dozens of contamination incidents associated with their eye drops.
The contaminant in question, Pseudomonas aeruginosa, is an extremely dangerous bacteria that can lead to drug and antibiotic-resistant infection. In turn, this infection has led to subsequent vision loss in some optometry patients who’ve used these products, and in at least one confirmed instance, a tragic loss of life. The CDC’s investigation into Global Pharma’s contaminated products would go on to lead to a voluntary FDA recall, with subsequent class action lawsuits following suit.
We now provide some updates that could result in more product liability suits.
The EzriCare Artificial Tears Recall
Global Pharma Healthcare initiated a recall on February 2, 2023. The drug recall was due to potential microbial contamination. The recall concerns “all lots within expiry of their Artificial Tears Lubricant Eye Drops, distributed by /EzriCare, LLC- and Delsam Pharma. . . .”
As FDA’s recall notice explains, “The Centers for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of Verona Integron-mediated Metallo-β-lactamase (VIM)- and Guiana-Extended Spectrum-β-Lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare. To date, there are 55 reports of adverse events including eye infections, permanent loss of vision, and a death with a bloodstream infection.” The risk at issue is that “[u]se of contaminated artificial tears can result in the risk of eye infections that could result in blindness.”
The FDA Recall Notice Company Details – Caution
FDA directs consumers with questions regarding this recall can contact the distributors: Aru Pharma/Ezricare, LLC by phone: 1-516-715-5181 or by e-mail: email@example.com from Monday to Friday, 11am to 4pm EST; or DELSAM Pharma LLC by phone: 1-866-826-1306 or by e-mail: firstname.lastname@example.org from Monday to Friday from 11am to 4pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
KBA is Here to Help
If you have been injured and you believe it is due to contaminated eye drops, contact a licensed healthcare professional right away. Before contacting the potential defendant as described above in the FDA recall, you should likely speak with an attorney. As we all know from criminal law, what you say can be used against you, so speak with an attorney.
We do not advocate stopping medical treatment without speaking with a medical provider. For legal advice, licensed attorneys, such as those at KBA Attorneys, have decades of experience navigating the complexities of product liability claims. Indeed, attorneys at KBA have handled outbreaks like this before. We have worked on food poisoning cases and viral infections from unsanitary distributors, including the infamous, NECC outbreak.
If you or a loved one are suffering from EzriCare artificial tears, you might have a claim. To learn more about our team and how we might be able to help you, contact our office by clicking here..
This post is informational. References to the CDC and FDA do not suggest a relationship with these agencies or endorsement of the views herein.