Central, state teams on way to Global Pharma Healthcare plant after firm recalls eye drop linked to vision loss in US
The USFDA noted that the "use of contaminated Artificial Tears can result in the risk of eye infections that could result in blindness".
New Delhi: Two teams from the central and state drug regulatory bodies will inspect Global Pharma Healthcare's manufacturing plant near Chennai after the company recalled its eye drop linked to vision loss in the US, official sources said on Friday. They said the specific eye drop is not sold in India.
"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 said.
The US Food and Drug Administration has said in a statement that the Chennai-based company is recalling all lots of Artificial Tears lubricant eye drops distributed by EzriCare, LLC and Delsam Pharma to the consumer level due to possible contamination.
To date, there are 55 reports of adverse events including eye infections, permanent loss of vision and a death with a bloodstream infection, it added.
The USFDA noted that the "use of contaminated Artificial Tears can result in the risk of eye infections that could result in blindness".
Artificial Tears lubricant eye drops are used as a protectant against irritation or to relieve dryness of the eye.
In a statement posted on its website, Global Pharma Healthcare said it is notifying the distributors of this product Aru Pharma Inc and Delsam Pharma, and is requesting that wholesalers, retailers and customers who have the recalled product should stop using it.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these over-the-counter drug products, it said.
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