Serious Infections Causing Vision Loss Have Been Linked to the Use of EzriCare Artificial Tears Lubricant Eye Drops
(Posted by Tom Lamb at Drug Injury Watch)
Today we pick up where our article from last week "EzriCare Artificial Tears Associated With Eye Infections: February 2023 CDC Warnings Issued" ended -- that is, we will be monitoring the CDC and FDA for further developments -- with news about an artificial tears eye drops recall involving EzriCare and Delsam Pharma’s Artificial Tears over-the-counter (OTC) products.
From this February 2, 2023 document, "FDA warns consumers not to purchase or use EzriCare Artificial Tears due to potential contamination":
Global Pharma initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears. FDA recommended this recall due to the company’s current good manufacturing practice (CGMP) violations, including lack of appropriate microbial testing, formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use bottles, without an adequate preservative), and lack of proper controls concerning tamper-evident packaging.
FDA is collaborating with the Centers for Disease Control and Prevention (CDC) and state and local health departments to investigate a multistate outbreak involving a rare, extensively drug-resistant strain of Pseudomonas aeruginosa bacteria. As of January 31, 2023, CDC identified 55 patients in 12 states with infections that have been linked by epidemiologic and laboratory evidence to use of EzriCare Artificial Tears. Associated adverse events include hospitalization, one death with bloodstream infection, and permanent vision loss from eye infections.
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This CDC Outbreak and Patient Notifications article, "Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa Associated with Artificial Tears", reported that as of January 31, 2023, those 55 patients were located in these 12 states:
- New Jersey
- New Mexico
- New York
The CDC article also provided in-depth information about a rare type of drug-resistant infection these patients had been diagnosed with after using EzriCare Artificial Tears lubricant eye drops, "VIM-GES-CRPA, a rare strain of extensively drug-resistant P. aeruginosa".
As a standard practice, when a drug company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. Here is the Global Pharma Healthcare announcement about this artificial tears eye drops recall involving EzriCare and Delsam Pharma’s Artificial Tears products in February 2023: "Global Pharma Healthcare Issues Voluntary Nationwide Recall of Artificial Tears Lubricant Eye Drops Due to Possible Contamination".
Importantly, this Global Pharma Healthcare recall announcement includes a "Product Photos" part at the end which will help people with identifying the particular over-the-counter (OTC) lubricant eye drops that are part of this February 2023 recall involving EzriCare and Delsam Pharma’s Artificial Tears products.
We are investigating Delsam Pharma’s Artificial Tears and EzriCare Artificial Tears lubricant eye drops cases involving hospitalization, death, or permanent vision loss from an eye infection as possible drug injury lawsuits that would be filed against Global Pharma Healthcare.
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