India's Central Drugs Standard Control Organisation has suspended the manufacturing of eye drops.
New Delhi: 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.
FDA has also restricted the imports of products manufactured by Chennai-based Global Pharma Private Healthcare Limited.
The US Centre for Disease Control (CDC) identified 55 patients in 12 states with infections that have been linked by epidemiologic and laboratory evidence to the use of EzriCare Artificial Tears.
As of January 31, 2023, CDC identified 55 patients in 12 states with infections that have been linked by epidemiologic and laboratory evidence to use of EzriCare Artificial Tears,it claimed further.
The associated adverse events include hospitalization, one death from bloodstream infection, and permanent vision loss from eye infections. The CDC has issued an alert recommending consumers stop using EzriCare Artificial Tears pending additional guidance from CDC and FDA.