US FDA issues alert on eye drop made by Indian firm following cases of vision loss and death

The US drug regulators have alerted consumers not to use EzriCare brand of artificial tear made by a Chennai-based company after an investigation found a suspected link between the eye drop and a drug resistant bacteria, leading to eye infections, vision loss and death.

Following the probe by the Centre for Disease Control, Atlanta, the manufacturer Global Pharma Healthcare Private Limited, at the behest of the US Food and Drug Administration has initiated a “voluntary recall” of all unexpired lots of the Artificial Tear, distributed by two firms in the US market.

In a statement, the US FDA recommended such a recall due to the company’s current good manufacturing practice (CGMP) violations, including lack of appropriate microbial testing, formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use bottles, without an adequate preservative), and lack of proper controls concerning tamper-evident packaging.

Teams from the CDSCO and TN State Drug Controller (three persons each) were on their way to the manufacturing plant near Chennai for inspection. But ANI quoting sources reported that this eye drop was sold in India.

The US regulatory step comes days after the CDC issued an alert following identification of 55 cases of infection in 12 states by an extensively drug-resistant strain of Pseudomonas aeruginosa bacteria. Associated adverse events include hospitalization, one death with bloodstream infection, and permanent vision loss from eye infections.

The company says it is voluntarily recalling all lots within expiry of their Artificial Tears Lubricant Eye Drops, distributed by EzriCare and Delsam Pharma, to the consumer level, due to possible contamination. “Global Pharma Healthcare is notifying the distributors of this product, Aru Pharma and Delsam Pharma and is requesting that wholesalers, retailers and customers who have the recalled product should stop use.”

In the last four months, this is the third instance of poor quality medicines manufactured by Indian firms causing adverse health consequences outside India. The previous two incidents were related to children deaths allegedly from the consumption of contaminated cough syrups in The Gambia and Uzbekistan.

While examining the outbreak in several US states, a review of common exposures revealed that most patients, including most patients with eye infections, used artificial tears prior to identification of the infection. Patients reported more than 10 brands of artificial tears, but the majority of patients used EzriCare Artificial Tears. Also this was the only common artificial tears product identified across the four healthcare facility clusters.

The CDC issued an alert recommending consumers to stop using EzriCare Artificial Tears, and alerted the FDA that recommended a recall. The FDA also placed the manufacturing firm Global Pharma Healthcare on import alert for providing an inadequate response to a records request and for not complying with CGMP requirements.