There were 55 unfavourable incidents, according to the US government agency Centre for Disease Control and Prevention, including eye infections, irreversible vision loss, and one death from a blood stream infection.
Chennai: After receiving notification from a US government agency that many adverse occurrences had occurred, likely as a result of the use of the eye drops, a Chennai-based business recalled its eye drops from the US market.
There were 55 unfavourable incidents, according to the US government agency Centre for Disease Control and Prevention, including eye infections, irreversible vision loss, and one death from a blood stream infection. Five persons who used the eye drops become entirely blind.
The Centers for Disease Control and Prevention was looking into the US distributors Ezricare, LLC and Delsam Pharma’s distribution of lubricating eye drops manufactured by Global Health Pharma. However, India does not sell the eye drops.
The US Food and Drug Administration (FDA) had urged anyone who had already acquired the medicine not to use it and had advised consumers and clinicians not to buy it from the market. “Using tainted artificial tears raises risk of eye infections that might result in blindness and death,” the FDA’s warning stated.
In order to stop the firm’s items from entering the US in the future, the company has now been added to the US FDA’s import alert list.
According to the FDA, the company’s manufacturing practises include improper microbiological testing, formulation difficulties, and a lack of effective controls surrounding tamper-evident packaging, which led to the FDA’s recommendation that the medicine be recalled from the market.
A team of drug inspectors from the Union government and the Tamil Nadu government performed a check at the company’s premises, which are located 40 kilometres south of Chennai, after the US FDA had issued the warning.
However, despite numerous requests for comment from the media, corporate officials remained silent.
