A Chennai-based pharmaceutical company, Global Pharma Healthcare, is recalling an entire consignment of eye drops linked to vision loss in the US, according to the US Food and Drug Administration. The country's health protection agency said drug-resistant bacteria could have contaminated the eye drop, which has been also linked to one death from a bloodstream infection.
The US Centre for Disease Control and Prevention is testing unopened bottles of EzriCare Artificial Tears eye drops, manufactured by the company, while the US Food and Drug Administration said it has moved to restrict imports of products made by the company.
To date, there have been 55 reports of adverse events, including eye infections, permanent loss of vision and a death with bloodstream infection, it added.
The USFDA underscored that "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.
The bacterium usually spreads to people in hospitals or other healthcare settings when they're exposed to contaminated water or soil, where it typically lives.
The India-made eye drops are the latest pharmaceutical product from the country to land under scrutiny after dozens of deaths among children in Gambia and Uzbekistan last year linked to cough syrups.
In a statement posted on its website, Global Pharma Healthcare said 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.
Global Pharma Healthcare produces and supplies a wide range of pharmaceutical formulations in several therapeutic forms to a variety of markets in Southeast Asia, Central America, LATAM, CIS, and Africa.
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