A drug-resistant bacteria outbreak that caused adverse events in at least 55 patients in the United States, including infections, blindness, and one death, has been linked to an eye drop made in India, according to the U.S. Food and Drug Administration (FDA).
The organisation claimed on Thursday that Global Pharma Healthcare Pvt Ltd. of India’s Artificial Tears eye drop has violated current good manufacturing practises and may be contaminated with bacteria.
The eye drop, which was distributed in the United States by EzriCare LLC and Delsam Pharma, has been voluntarily recalled at the consumer level, according to Global Pharma Healthcare, based in the southern city of Chennai.
When Reuters contacted Global Pharma Healthcare for comment regarding the FDA statement, they did not respond right away.
The eye drop’s distributor and seller, EzriCare, announced in a statement on Wednesday that it had ceased operations and that it was not aware of any testing that ‘definitively links’ the bacterial outbreak to the product.
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