A Chennai-based company has recalled its eye drops from the US market after a US government agency has 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 blood stream infection. Five people turned completely blind on using the eye drops.
Global Health pharma’s product lubricant eye drops distributed by Ezricare, LLC and Delsam Pharma in the US was being investigated by the Centre for Disease Control and Prevention. However, the eye drops are not sold in India.
The US Food and Drug Administration (FDA) had instructed doctors and consumers not to purchase the product from the market and warned those who have already purchased not to use it. The warning issued by the FDA read, “Using contaminated artificial tears increases 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 that is aimed at preventing the company’s products from further entering the US.
The FDA has also stated that it had recommended the recall of the drug from the market due to manufacturing violations of the company that include lack of appropriate microbial testing, formulation issues and lack of proper controls regarding tamper-evident packaging.
After the US FDA had issued the warning, a group of drug inspectors from the Union government and Tamil Nadu government conducted an inspection at the company premises which is 40 km south of Chennai.
However, the company authorities did not speak to the media even after repeated questions.