Indian Co Global Pharma Healthcare Recalls Eye Drops Over 55 Adverse Events In US
Chennai-based drug firm Global Pharma Healthcare is voluntarily recalling all lots within expiry of their Artificial Tears Lubricant Eye Drops, distributed by /EzriCare, LLC- and Delsam Pharma, to the consumer level In the US, due to possible contamination, the USFDA on Thursday said in a statement.
The top US regulator informed that the Centers for Disease Control and Prevention (CDC) alerted FDA to investigate infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare.
The regulatory agency said that to date, there are 55 reports of adverse events including eye infections, permanent loss of vision, and one death with a bloodstream infection. The product was distributed Nationwide in the USA over the Internet.
USFDA has also issued a risk statement for the product which reads that the "use of contaminated artificial tears can result in the risk of eye infections that could result in blindness".
As per the media reports, two regulatory teams of CDSCO (Central Drug Standard Control Organisation and the State Drug Controller rushed to the company's plant in Chennai to inspect the matter on Friday.
Artificial Tears (carboxymethylcellulose sodium) Lubricant Eye Drops, 10 mg in 1 mL, ½ fl oz (15 ml) bottle are used as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun.
Global Pharma Healthcare 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 use, the USFDA said.
