After an Indian company, Global Pharma Healthcare Private Limited recalled a line of eye drops related to eyesight loss from the US market, two teams from the national and state drug regulatory organisations will inspect the company's production plant near Chennai, according to the official sources. However, the sources stated that the precise eye drop is not sold in India, news agency PTI reported.
The product, Artificial Tears, is distributed by EzriCare and Delsam Pharma and sold online across the US in multidose bottles.
"Teams from CDSCO (Central Drugs Standard Control Organisation) and State Drug Controller (three persons each) are on their way to the plant located about 40 km south of Chennai. It is a contract manufacturing plant supplying through others to the US market. This specific drug is not sold in India," one of the sources was quoted by PTI in its report.
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According to the US Food and Drug Administration, the Chennai-based business is recalling all lots of Artificial Tears lubricating eye drops provided to consumers by EzriCare, LLC and Delsam Pharma owing to suspected contamination.
There have been 55 reports of adverse events, including eye infections, irreversible vision loss, and death from a bloodstream infection, according to the company.
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.
(With Inputs From PTI)