FDA publishes report stating Global Pharma’s eye drops broke safety norms
pharmafile | April 4, 2023 | News story | Medical Communications |
The FDA has published a report revealing that Global Pharma’s plant in India’s Chennai city failed to achieve safety norms throughout multiple observations.
In February 2023, the eye drops, under the brand names EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears, were recalled after a recommendation from the FDA, which then stopped the import of the products to the US. At the time of recall, 55 reports of negative effects such as eye infections, permanent loss of vision and at least one death had been reported.
The FDA conducted an 11-day inspection of the Global Pharma plant, where several violations were observed. The report states that the surfaces which came into contact with the drug packaging “were not cleaned, sanitized, decontaminated or sterilised.”
In March 2023, the Centers for Disease Control and Prevention (CDC) revealed 68 patients had been infected with a rare strain of Pseudomonas aeruginosa. Three people have died, eight people suffered vision loss and four had to have their eye surgically removed.
The CDC has also voiced its concern of the strain gaining a foothold in the US. It had never been detected in the country before this incident, and can spread from people who don’t have symptoms and to those who haven’t used the eye drops, especially in medical situations; cases have already been reported in hospitals, long-term care facilities, emergency departments and urgent care clinics. Lead investigator for the CDC’s antimicrobial resistance team, Maroya Walters stated: “I think we are going to see the impact of this play out over the course of months to years.”
James Spargo
