“Due to a potential bacterial contamination, FDA is advising consumers and healthcare professionals not to purchase and to stop using EzriCare/ Pharma’s artificial tears right away.
The US Health and Human Services Department warned that a line of tears eye drops manufactured by a Chennai-based pharmaceutical company could be contaminated with a drug-resistant bacteria that has been linked to reports of permanent vision loss and one death from a bloodstream infection.
While the US Food and Drug Administration (FDA) announced it has taken action to restrict imports of goods produced by the company, the US Centers for Disease Control and Prevention (CDC) is testing unopened bottles of Global Pharma Healthcare’s EzriCare artificial tears eye drops.
“Due to a potential bacterial contamination, the FDA is advising consumers and healthcare professionals not to purchase and to stop using EzriCare or Delsam Pharma’s artificial tears right away. “Using tainted artificial tears increases the risk of eye infections, which can be fatal or cause blindness,” “said the agency on Thursday.
In a previous statement, Global Pharma Healthcare said that it was “voluntarily recalling all lots of their artificial tears lubricant eye drops, distributed by EzriCare, LLC, and Delsam Pharma, to the consumer level, due to possible contamination.”
According to CBS News, doctors across the nation have been warned about an unprecedented Pseudomonas aeruginosa outbreak that has affected at least 55 people in 12 states and resulted in at least one death.
The network cited a CDC spokesperson as saying that so far, at least five of the 11 patients who have had infections directly in their eyes have lost their vision.
Teams from the State Drug Controller and the Central Drugs Standard Control Organization (CDSCO) are en route to the Global Pharma Healthcare plant, which is located about 40 kilometres south of Chennai. According to Insider.com, Pseudomonas aeruginosa can lead to infections in the blood, lungs, or wounds.
In recent years, however, antibiotic resistance has made the germ more difficult to treat. According to the CDC, the bacterium typically spreads to people in hospitals or other healthcare environments when they are exposed to tainted water or soil, where it usually lives.
Following dozens of child deaths in the Gambia and Uzbekistan last year that were linked to cough syrups, the brand of eye drops made in India is the most recent pharmaceutical product from the nation to come under scrutiny.
Following allegations from the US Food and Drug Administration (US FDA) that 55 cases of adverse events were linked to tainted eye drops, India’s Central Drug Standard Control Organization (CDSCO) has halted the production of eye drops at the Chennai-based company.