CDSCO suspends manufacturing of eye drops linked to 55 adverse events in US
FDA also placed Global Pharma Healthcare Private Limited on import alert for providing an inadequate response to a records request and for not complying with CGMP requirement.;
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New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has suspended the manufacturing of eye drops and initiated its probe after the United States' Food and Drug Administration (FDA) allegedly linked 55 adverse events cases with contaminated eye drops, sources said on Saturday adding that the investigating agencies in both the countries are constantly investigating the matter.
According to the people aware of the matter, the US-based Food and Drug Administration has warned the consumers "not to purchase or use EzriCare Artificial Tears due to potential contamination", and the Union Health Ministry's CDSCO and Tamil Nadu's State Drug Controller have initiated a probe into the matter.
"Teams from CDSCO and TN State Drug Controller (three persons each) are on their way to the manufacturing plant located near Chennai. It's a contract manufacturing plant supplying through others to the US market. This specific drug is not sold in India," it said.
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