Twelve US states have been investigating Global Pharma Healthcare, which makes the eye drop known as Artificial Tears.
According to the US Food and Drug Administration, Global Pharma Healthcare is recalling all lots of eye drops that have been connected to cases of vision loss in the United States.
As a precaution against probable contamination, the US health agency has issued a recall for all batches of artificial tears lubricant eye drops manufactured and sold by Chennai-based business EzriCare, LLC and Delsam Pharma.
“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.
Among the 55 reported adverse effects include infections of the eye, loss of eyesight, and even death due to a bloodstream infection.
The USFDA noted that “use of contaminated artificial tears can result in the risk of eye infections that could result in blindness”. Lubricant eye drops like Artificial Tears are applied to the eye as a preventative measure against irritation or as a treatment for dry eyes.
According to a statement published on the company's website, Global Pharma Healthcare has notified the product's distributors, Aru Pharma Inc and Delsam Pharma, and has asked that any wholesalers, merchants, or consumers in possession of the recalled product immediately cease using it.
It advised consumers who have encountered adverse effects while using these OTC medications to speak with their doctor or healthcare practitioner.
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With a focus on markets in Southeast Asia, Central America, LATAM, the Commonwealth of Independent States, and Africa, Global Pharma Healthcare manufactures and distributes a broad selection of pharmaceutical formulations in many therapeutic forms.
The Chennai-based company's eye drop is the latest Indian product to face investigation after cough syrups made there were connected to the deaths of infants in the Gambia and Uzbekistan.
(With inputs from PTI)
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