A Chennai-based pharmaceutical company has suspended the production of a line of eye drops from the US market after the country's health protection agency said they could be contaminated with a drug-resistant bacteria that have been linked to reports of permanent vision loss and one death from a bloodstream infection.
Teams from Central Drugs Standard Control Organisation (CDSCO) and State Drug Controller are on their way to the Global Pharma Healthcare plant located about 40 km south of Chennai.
The US Centers for Disease Control and Prevention (CDC) is testing unopened bottles of EzriCare Artificial Tears eye drops, manufactured by Global Pharma Healthcare, while the US Food and Drug Administration (FDA) said it has moved to restrict imports of products made by the company.
"FDA is warning consumers and health care practitioners not to purchase and immediately stop using EzriCare Artificial Tears or Delsam Pharma's Artificial Tears due to potential bacterial contamination. Using contaminated artificial tears increases risk of eye infections that could result in blindness or death," the agency said on Thursday.
Earlier, Global Pharma Healthcare had issued a statement, saying the company "is voluntarily recalling all lots within expiry of their Artificial Tears Lubricant Eye Drops, distributed by /EzriCare, LLC- and Delsam Pharma, to the consumer level, due to possible contamination".
Doctors around the country have been alerted to an unprecedented outbreak of Pseudomonas aeruginosa, affecting at least 55 people across a dozen states, and at least one death, CBS News reported.
So far, at least five of the 11 patients who have had infections directly in their eyes have lost their vision, a CDC spokesperson was quoted as saying by the network.
Pseudomonas aeruginosa can cause infections in the blood, lungs, or wounds and the germ has been proving tougher to treat in recent times because of antibiotic resistance, Insider.com reported.
The bacterium usually spreads to people in hospitals or other healthcare settings when they're exposed to contaminated water or soil, where it typically lives, according to the CDC.
The India-made brand of eye drops are the latest pharmaceutical product from the country to land under scrutiny after dozens of deaths among children in Gambia and Uzbekistan last year linked to cough syrups.