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regular-article-logo Friday, 21 June 2024

Indian firm’s eye drop linked to death in US

US Food and Drug Administration asked consumers and healthcare practitioners not to purchase and immediately discontinue using EzriCare Artificial Tears, citing potential bacterial contamination

G.S. Mudur New Delhi Published 04.02.23, 03:37 AM
A Global Pharma executive and Indian drug officials said the product is not sold in India

A Global Pharma executive and Indian drug officials said the product is not sold in India Representational picture

US health authorities have warned consumers not to use a brand of artificial tears made by an Indian company, Global Pharma Healthcare, after an investigation linked the eye drops to bacterial infections, vision loss and one death in the US.

The US Food and Drug Administration (FDA), in a drug safety alert released on Thursday, asked consumers and healthcare practitioners not to purchase and immediately discontinue using EzriCare Artificial Tears, citing potential bacterial contamination.

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The FDA also said it had “recommended” a recall of all unexpired lots of EzriCare Artificial Tears due to the company’s violations of good manufacturing practices, including lack of appropriate microbial tests, formulation issues, and lack of proper controls concerning tamper-evident packaging.

A Global Pharma executive and Indian drug officials said the product is not sold in India. But the FDA notice has triggered a probe in India. Central and Tamil Nadu state drug regulators were on Friday on their way to Global Pharma’s plant about 40km south of Chennai.

“It is a contract manufacturing plant that supplies through others to the US market,” an official who requested anonymity said. The EzriCare Artificial Tears are over-the-counter products and intended to be sterile.

The FDA said it is collaborating with the US Centres for Disease Control and Prevention and state and local health departments to investigate an outbreak in 12 states involving a rare, extensively drug-resistant bacterial infection.

The CDC said laboratory testing had identified the presence of the outbreak bacterial strain in opened EzriCare bottles with different lot numbers collected from two states. The strain could represent either bacterial contamination during use or during the manufacturing process, it said.

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