Global Pharma Healthcare is recalling eye drops linked to vision loss in the United States, according to the US Food and Drug Administration. The Chennai-based company is recalling all lots of the eye drops distributed by EzriCare, LLC and Delsam Pharma. The firm is taking this action after reports of possible contamination.
"The Centres for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of Verona Integron-mediated Metallo-β-lactamase (VIM)- and Guiana-Extended Spectrum-β-Lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare," USFDA said.
There are 55 reports of adverse events including eye infections, permanent loss of vision and death with a bloodstream infection, it added.
The USFDA said 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 if they have experienced any problems that may be related to using these over-the-counter drug products, it said. Global Pharma Healthcare produces a wide range of pharmaceutical formulations in several therapeutic forms to a variety of markets in Southeast Asia, Central America, LATAM, CIS, and Africa.
The eye drop produced by the Chennai-based firm is the latest product from the country to come under scrutiny. Some cough syrups were linked to child deaths in Gambia and Uzbekistan.
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