Chennai Pharma Firm Asked To Halt Production Of Eye Drops Related To 'Vision Loss' In US: Report
There have been 55 reports of adverse events, including eye infections, irreversible vision loss, and death from a bloodstream infection, according to the company.
New Delhi: As part of the ongoing investigation on the India-manufactured eyedrops that resulted in alleged vision loss in the United States, officials said the Chennai-based firm Global Health Care Pvt Ltd had exported two consignments of 24 batches of 'Artificial Tears' to USA which were manufactured in 2021 and 2022, news agency ANI reported.
According to the report, the manufacturer has been instructed to stop the manufacturing activities of all the products under the category of ophthalmic preparation till the completion of the investigation.
During the investigation by senior drug inspectors, it was found that Chennai-based firm Global Health Care Pvt Ltd had exported two consignments of 24 batches of 'Artificial Tears' to USA which were manufactured in 2021 and 2022: Sources
— ANI (@ANI) February 4, 2023
The samples were taken for analysis from four batches of control samples. The sample of raw material Carboxy Methyl Cellulose Sodium was also taken, officials told ANI.
It is to be noted that the Chennai-based company recalled a line of eye drops related to reports on eyesight loss from the US market. However, officials said that the eyedrop is not sold in India.
Notably, there have been 55 reports of adverse events, including eye infections, irreversible vision loss, and death from a bloodstream infection, according to the company.
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The USFDA stated that the "use of contaminated Artificial Tears can result in the risk of eye infections that could result in blindness."
Artificial Tears lubricating eye drops are used to protect the eyes from irritation or to treat dryness.
Global Pharma Healthcare stated on its website that it is alerting the product's distributors, Aru Pharma Inc and Delsam Pharma, and that wholesalers, retailers, and consumers who have the recalled product should cease using it.
It advised consumers to consult their physician or healthcare provider if they had any issues while taking these over-the-counter medication goods.