New Delhi: The manufacturer of eye drops that have been linked to an outbreak of serious bacterial infections in the US, including at least three deaths, did not follow proper protocol to prevent contamination of its products, according to an inspection report by the US Food and Drug Administration.
According to the CNN, the FDA visited a Global Pharma Healthcare facility in India for an inspection that started in mid-February, two weeks after the company recalled EzriCare Artificial Tears due to possible contamination.
At the time of the recall, there were 55 reports of adverse events including eye infections, permanent loss of vision and at least one death with a bloodstream infection. As of late last month, 68 infections had been identified in 16 states, according to the US Centers for Disease Control and Prevention.
There have been three deaths, eight cases of vision loss and four surgical eye removals reported, the CNN reported.
Three deaths, eight cases of vision loss and four surgical eye removals have been reported after the use of products from India
India’s Global Pharma Healthcare claimed on Tuesday no contamination was found in samples of eye drops made by the company, a product linked to three deaths and blindness in some patients in the US.
Broadcaster NDTV reported, citing India’s health ministry sources, the tests found the samples to be of “standard quality”.
The tests have been conducted nearly two months after US agencies warned against using the Artificial Tears eye drops, citing potential contamination by drug-resistant bacteria.
Spokespeople for India’s health ministry and Global Pharma Healthcare Pvt Ltd did not immediately respond to a request for comment.
The company issued a nationwide voluntary recall of the product in February due to possible contamination, according to the US Food and Drug Administration (FDA), which said the firm had violated good manufacturing practices.
The US Centers for Disease Control and Prevention (CDC) had identified the presence of “a rare strain of extensively drug-resistant” bacteria in 68 patients in 16 states, most of whom reported using Artificial Tears eye drops, as of March 14.
At least three people have died, and there have been eight reports of vision loss and four reports of surgical removal of an eyeball, according to the CDC.
The incident follows the deaths of at least 70 children in Gambia and 19 children in Uzbekistan last year that were linked to Indian-made cough syrups, which hurt the country’s image as the “pharmacy of the world”.
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