Chennai Pharma Company Recalls ‘Artificial Tears’ From US Market After 5 Cases Of Vision loss, One Death

Global Pharma Healthcare, a Chennai-based pharmaceutical company, has recalled its eyedrops sold in the US under the brand names EzriCare, and Delsam Pharma over possible contamination with Pseudomonas aeruginosa, a bacteria found on the hands of otherwise healthy people.

CDC investigators found the bacteria in bottles of eyedrops and are now doing tests to determine whether it matches the strain found in patients. It is unclear whether the contamination occurred during manufacturing or when consumers opened bottles.

EzriCare

Infections reported in 12 US states

The product was distributed across the USA over the Internet.

The recall was announced on Thursday after EzriCare, which is said to be an artificial lubricator, was found to have been linked to at least 55 cases of bacterial infection in 12 US states, out of which five people have had vision loss.

Infections have been reported in California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah, Washington and Wisconsin.

One person has also reportedly died after the bacteria entered the bloodstream.

EzriCare

FDA restricts Global Pharma’s import

Earlier, the Centers for Disease Control and Prevention alerted the US FDA about the possible contamination and urged people to stop using the eye drops immediately.

The FDA has also placed Global Pharma Healthcare Private Limited on import alert for providing an inadequate response to a records request and for not complying with CGMP requirements. 

What is the risk?

In a statement, also published on the US FDA website, Global Pharma said the use of contaminated artificial tears can result in the risk of eye infections that could result in blindness.

It also asked consumers to contact their physician or healthcare provider if they have experienced any problems using these over-the-counter drug products. “Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program,” it said further.

Made in India drugs under scanner again 

This is the third case in recent times when drugs manufactured by Indian pharma companies have come under international scrutiny over their quality.

In October, it was alleged that the death of 69 children in the Gambia in West Africa was linked to four cough syrups made by Haryana-based Maiden Pharmaceuticals.

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Though the WHO had claimed that the deaths were linked to the Indian-made cough syrups, an investigation in India ruled it out.

Cough syrup deaths in Uzbekistan 

Last month the WHO again alerted against using two Indian cough syrups – Ambronol and DOK-1 Max in Uzbekistan.

indian-cough-syrups

According to Uzbek authorities, the two cough syrups manufactured by Noida-based Marion Biotech Pvt Ltd were linked to the death of 19 children in the country.

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