This is an archive article published on February 3, 2023
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Chennai pharma recalls eye drop after infections in US, unit’s inspection on
A day after the US Food and Drug Administration posted the company's announcement, asking people to stop selling and using the eye drop, a joint team of six central and state drug inspectors rushed to the company's plant located 40km south of Chennai on Friday evening.
FILE - This scanning electron microscope image made available by the Centers for Disease Control and Prevention shows rod-shaped Pseudomonas aeruginosa bacteria. U.S. health officials are advising people to stop using the over-the-counter eye drops, EzriCare Artificial Tears, that have been linked to an outbreak of drug-resistant infections of Pseudomonas aeruginosa. (AP)
On the heels of two incidents of India-manufactured syrups being linked to deaths of children in the Gambia and Uzbekistan, a Tamil Nadu-based company has voluntarily recalled its eye drop from the US after it was linked to a drug resistant infection. The eye drop has been linked to 55 incidents of infections, loss of vision, and even a death due to the infection entering the bloodstream.
“It is a contract manufacturing plant supplying through others to the US market. This specific drug is not sold in India,” sources from the Health ministry said. The company in its announcement said that the eye drop was distributed by ErziCare and Delsam Pharma.
The medicine, which is used to relieve irritation or dryness of the eye, is sold over-the-counter. “The product was distributed nationwide in the US over the internet,” the company said in its statement.
The Centre for Disease Control and Prevention reported the multi-state cluster of a bacteria called pseudomonas aeruginosa that was resistant to third-line antibiotic called Carbapenem.
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Unlike the incidents in the Gambia and Uzbekistan, where the manufacturing was stopped by Indian authorities after concerns were raised, the Chennai company recalled the product themselves. The process followed by the Indian regulator was, however, the same with an inspection of the plant being carried out soon after the reports.
After similar inspections found the companies in Haryana and Uttar Pradesh not adhering to good manufacturing practices, the facilities were shut down by the Indian regulator. A risk-based inspection of drug manufacturing companies was carried out thereafter.
In Uzbekistan, 18 children died of kidney failure allegedly after consuming two syrups manufactured by Marion Biotech. While in the Gambia, the deaths of 70 children due to acute kidney injury were linked to four syrups manufactured by Maiden pharma. In both cases, the syrups allegedly contained the contaminants — di-ethylene glycol and ethylene glycol.
FILE - This scanning electron microscope image made available by the Centers for Disease Control and Prevention shows rod-shaped Pseudomonas aeruginosa bacteria. U.S. health officials are advising people to stop using the over-the-counter eye drops, EzriCare Artificial Tears, that have been linked to an outbreak of drug-resistant infections of Pseudomonas aeruginosa. (AP) 
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