Killer bacteria in eye drops: Global Pharma Healthcare recalls 50,000 tubes of contaminated eye drops in the United States. A Pseudomonas aeruginosa strain linked to the use of artificial tears from widely used brands
alarm in the United States for a drug-resistant killer bacterium causing serious infections that have caused loss of vision in eight people, three deaths and four operations for the surgical removal of the eyeball. Chennai-based drugmaker Global Pharma Healthcare is recalling 50,000 bottles of eye drops in the US market due to “microbial contamination,” according to an update from the US Food and Drug Administration (USFDA). The US Food & Drug Administration (FDA) said in its Enforcement Report that the pharmaceutical company was recalling eye lubricant for artificial tears linked to vision loss in the United States. The eye drops produced by the Indian company marketed in the United States by Deslam Pharma, based in New York. Global Pharma Healthcare is voluntarily recalling Lot No. H29 of the artificial eye ointment, distributed by Delsam Pharma at the consumer level, due to possible microbial contamination. Additionally, some product packaging is leaking or may otherwise be compromised,” the report said. The report also mentioned that “FDA analysis found unopened tubes were contaminated with bacteria.” Global Pharma reportedly initiated a Class I recall on February 24, 2023. According to the US drug regulator’s website, a Class I recall has the highest priority among all three types of recalls in the US pharmaceutical industry and is applicable to most defective products The cause is a strain of Pseudomonas aeruginosa linked to the use of artificial tears from widely used brands, the notice came from the Centers for Disease Control (CDC), which are collaborating with the Food and Drug Administration (FDA) and departments state and local health officials to investigate the outbreak According to the CDC, infection has been reported in 68 patients who have used various artificial tear products and eye drops in at least 16 states. The bacteria, which the CDC describes as largely drug resistant, are associated with multiple types of infections, including eye infections. According to health officials, all 68 patients reported using different types of eye drops before noticing symptoms, prompting recalls of three brands: EzriCare Artificial Tears, Delsam Pharma Artificial Tears and Delsam Artificial Eye Ointment. The epidemic strain, carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA), the CDC explained, had never been reported in the United States prior to this outbreak. US authorities advise patients who have used these products to seek immediate medical attention if they experience signs or symptoms of an eye infection, which may include: yellow, green, or clear discharge from the eye, eye pain or discomfort, redness of the eye or eyelid, sensation of something in the eye, increased sensitivity to light, blurred vision. At the moment, the CDC, notes Giovanni D’Agata, president of the Rights Desk, does not recommend testing patients who have used the product, but do not show any signs or symptoms of infection but they are encouraged to report adverse effects and ask your doctor about alternative treatment options.