US FDA says India-made eye drop linked to some infections, blindness and one death
(VOVWORLD) - The US Food and Drug Administration (FDA) has warned against using an eye drop made in India that has been linked to the outbreak of a drug-resistant bacteria leading to adverse events in at least 55 patients in the United States including infections, blindness and one death.
 Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, US, August 29, 2020. (Photo: REUTERS) |
The agency said last week that Artificial Tears eye drop manufactured by India's Global Pharma Healthcare has a potential bacterial contamination and the company has violated current good manufacturing practices.
Global Pharma Healthcare, based in the southern city of Chennai, said earlier it had issued a voluntary recall at the consumer level of unexpired lots of the eye drop, which was distributed in the United States by EzriCare and Delsam Pharma.
An Indian government source told Reuters on Friday that the federal and state drug regulators have sent a team to a manufacturing plant near Chennai contracted by Global Pharma Healthcare.