Updates About Bacterial Contamination Problem for These Over-The-Counter (OTC) Eye Products Given by FDA and CDC
On February 21, 2023, and February 22, 2023, there were updates to this FDA document, "FDA warns consumers not to purchase or use EzriCare Artificial Tears due to potential contamination", which was initially issued on February 2, 2023. A first update was about the Delsam Pharma’s Artificial Eye Ointment warning not to purchase or use this OTC eye product. A second update, one day later, was about the Delsam Pharma’s Artificial Eye Ointment recall by Global Pharma Healthcare Private Limited.
In addition, this CDC Healthcare-Associated Infections (HAIs) document, "Outbreak of Extensively Drug-resistant Pseudomonas aeruginosa Associated with Artificial Tears", was updated on or about February 21, 2023 (accessed 2/22/23) in order to provide an increased case count -- reported to be 58, up from 55 -- and to inform that there was a new case in one more state -- adding Illinois. From that updated CDC document:
As of February 21, 2023, CDC, in partnership with state and local health departments, identified 58 patients in 13 states (CA, CO, CT, FL, IL, NJ, NM, NY, NV, TX, UT, WA, WI) with VIM-GES-CRPA, a rare strain of extensively drug-resistant P. aeruginosa. Thirty-five patients were linked to four healthcare facility clusters. One person has died and there have been 5 reports of vision loss. Dates of specimen collection were from May 2022 to January 2023. Isolates have been identified from clinical cultures of sputum or bronchial wash (13), cornea (12), urine (9), other nonsterile sources (4), and blood (2), and from rectal swabs (25) collected for surveillance; some patients had specimens collected from more than one anatomic site.
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Here are two earlier articles we wrote about a similar bacterial contamination problem for two other OTC eye products from Global Pharma, EzriCare Artificial Tears and EzriCare Artificial Tears lubricant eye drops.
- "EzriCare Artificial Tears Associated With Eye Infections: February 2023 CDC Warnings Issued" (2/2/23)
- "Artificial Tears Eye Drops Recall Involving EzriCare and Delsam Pharma's Products in February 2023" (2/7/23)
We are investigating cases involving hospitalization, death, or permanent vision loss from an eye infection due to the use of Delsam Pharma’s Artificial Eye Ointment, Delsam Pharma’s Artificial Tears, or EzriCare Artificial Tears lubricant eye drops. These cases are possible drug injury lawsuits that would be filed against Global Pharma.
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