An Indian company, Global Pharma Healthcare Private Limited, has recalled a line of eye drops from the US market after it was linked to a drug-resistant bacteria strain that has led to death of one person and vision loss in five others, a report in NYT said. The product, Artificial Tears, is distributed by EzriCare and Delsam Pharma and sold online across the US in multidose bottles.
Global Pharma, in a statement, said that it was recalling the eye drops “out of an abundance of caution”.
“Global Pharma is fully cooperating with US federal authorities, and is continuing to investigate this matter, but thus far we have not determined whether our manufacturing facility is the source of the contamination,” the company said in astatement.
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The Centers for Disease Control and Prevention (CDC) has advised people to stop using the eye drops.
The CDC said it was investigating an outbreak of a strain of the bacteria pseudomonas aeruginosa, which can cause infections in the blood, lungs and other parts of the body. This strain of the bacteria had never been identified in the US.
So far, the bacteria strain has been found in 55 people in 12 states. The agency said that the infections had caused one death, vision loss in five of 11 people who had eye infections, and some hospitalisations, NYT reported.
Most of those affected used artificial tears before the infections. The CDC said that it had found the drug-resistant bacteria strain in opened bottles of the EzriCare eye drops collected from patients with and without eye infections.
The CDC said people who have used EzriCare Artificial Tears and felt discomfort in their eyes should seek immediate medical care. The symptoms can include yellow, green or clear discharge from the eye, redness of the eye or eyelid, increased sensitivity to light and eye pain or discomfort, the NYT report said quoting CDC.
The Food and Drug Administration has said that it had moved to restrict imports of the products. The FDA cited multiple violations of manufacturing regulations by Global Pharma, including a “lack of appropriate microbial testing” and a “lack of proper controls concerning tamper-evident packaging”.
Global Pharma’s eye drop is the latest pharmaceutical product from India to come under lens of regulatory authorities after dozens of deaths among children in Gambia and Uzbekistan last year were linked to cough syrups manufactured by Indian firms.