According to the top regulator in the US, the manufacturer of eye drops based in India, which has been linked to three deaths and severe infections, had breached multiple safety regulations.
The Food and Drug Administration (FDA) conducted an inspection of Global Pharma's facility in Chennai, India, and released a report last week.
The company recalled the eye drops in February after a recommendation from the FDA. The FDA also banned the import of the product.
Two brands of eye drops – EzriCare Artificial Tears and Delsam Pharma's Artificial Tears, which were manufactured in India by Global Pharma and imported to the US, have been associated with a fatal outbreak of drug-resistant infections in the US.
In March, the Centres for Disease Control and Prevention (CDC) in the US reported that 68 individuals across 16 states had been diagnosed with a rare type of Pseudomonas aeruginosa, which can lead to severe infections, particularly in people with weakened immune systems.
This drug-resistant strain had not been discovered in the US prior to the most recent epidemic.
As per the BBC report in March, besides the fatalities, eight patients experienced a loss of vision, while four had to undergo eye surgery to remove their eye.
In February, EzriCare Artificial Tears stated on its website that they had been contacting customers to discourage them from using the product, to the best of their abilities.
However, the company claimed to not be involved in the actual production of the eye drops, despite marketing them.
Initially, the recall was limited to EzriCare Artificial Tears Lubricant and Delsam Pharma Artificial Tears Lubricant eye drops, but it was subsequently expanded to include a Delsam Pharma eye ointment.
Additionally, according to the agency's report, during an 11-day inspection of the Global Pharma plant in India, which started on February 20, the FDA identified multiple infringements of sterilisation and hygiene protocols.
The sterile manufacturing environment had several items that were not adequately cleaned, including a bowl with a greasy deposit.
The FDA's report also stated that surfaces that came into touch with drug packaging were not appropriately cleaned, decontaminated, sanitised or sterilised.
The CDC also expressed concern that the bacteria associated with the contaminated eye drops could establish itself in the US healthcare system, a report in The New York Times on Monday (03) informed.
The CDC had previously advised individuals who had used the recalled products and were experiencing symptoms to consult a physician.
Symptoms included a discharge from the eye that was yellow, green, or clear, discomfort or pain, redness, blurry vision, and heightened sensitivity to light.
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