US FDA issues alert on eye drop made by Chennai-based Pharma firm following cases of vision loss and death
After a Chennai-based pharmaceutical company was flagged by US authorities for fatal contamination in a line of eye drops, Tamil Nadu’s Drug Controller and members from the Central Drug Control Authority conducted a late-night inspection of Global Pharma Healthcare Private Limited.
Global Pharma Healthcare – the pharma company, recalled its eye drops from the US market after a US government agency informed the company that several adverse events had taken place, probably due to the usage of the eye drops.
The US government agency Centre for Disease Control and Prevention said there were 55 adverse cases including eye infections, permanent loss of vision, and one death due to a bloodstream infection. Five people turned completely blind to using the eye drops.
Global Health pharma’s product lubricant eye drops distributed by Ezricare, LLC and Delsam Pharma in the US were being investigated by the Centre for Disease Control and Prevention. However, eye drops are not sold in India.
Global Pharma Healthcare said it’s working closely with the US Food and Drug Administration (FDA). It has also advised consumers in the US to stop using the product and asked those experiencing adverse effects to seek medical help immediately, besides reporting on a portal it has set up or on its telephone helplines.
The US Centers for Disease Control and Prevention (CDC) is testing unopened bottles of EzriCare Artificial Tears eye drops, manufactured by Global Pharma Healthcare, while FDA said it has moved to restrict imports of products made by the company.
The US Food and Drug Administration (FDA) instructed doctors and consumers not to purchase the product from the market and warned those who have already purchased it not to use it. The warning issued by the FDA read, “Using contaminated artificial tears increases the risk of eye infections that could result in blindness and death.”
The company has now been placed on the US FDA’s import alert list which is aimed at preventing the company’s products from further entering the US.
[With Inputs from IANS]
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Total lack of quality, understanding & utterly careless Indian organizations. They have no sensitivity nor maintenance of its documentation. Indian business deserve to get backlash from international agencies and suffer to know the true impact of their manufacturing defeciencies