The US FDA has expanded its warning against eye therapies produced by Global Pharma Healthcare to cover an artificial eye ointment, following reports of contamination of its artificial tears products that have been linked with blindness and one death.
It comes after a 2 February announcement by the Food and drug Administration (FDA) that Global Pharma Healthcare was voluntarily recalling its Artificial Tears Lubricant Eye Drops, distributed to consumers as EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears over the internet, due to possible contamination.
The alleged contamination involves “carbapenem-resistant Pseudomonas aeruginosa”, a rare strain of extensively drug-resistant bacteria.
Authorities 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 included hospitalisation, one death with bloodstream infection, and permanent vision loss from eye infections.
On 23 February, the FDA issued an update to cover an eye ointment produced by the same manufacturer.
“Global Pharma Healthcare is voluntarily recalling Batch No. H29 of Artificial Eye Ointment, distributed by Delsam Pharma to the consumer level, due to possible microbial contamination,” the US drug regulator said.
“Additionally, some product packaging is leaking or may otherwise be compromised.
“Use of contaminated eye ointment may cause adverse events, including infection in the eye that could lead to blindness. To date, Global Pharma Healthcare has not received any reports of adverse events related to this product.”
The extended warning comes after the FDA identified violation of the company’s current good manufacturing practices.
This included a 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.
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