Global Pharma Healthcare is recalling entire lots of eye drop linked to vision loss in the US, according to the US Food and Drug Administration.
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, the US health regulator said in a statement.
"The Centres for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of Verona Integron-mediated Metallo-ß-lactamase (VIM)- and Guiana-Extended Spectrum-ß-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.
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 "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.
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.
The eye drop produced by the Chennai-based firm is the latest product from the country to come under scrutiny after some cough syrups were linked to children deaths in Gambia and Uzbekistan.