The US drug regulator has issued an alert to immediately halt use and importation of an artificial tears eye drops manufactured in India that has been linked to permanent vision loss and one death.
On 2 February, the Food and drug Administration (FDA) said Global Pharma Healthcare was voluntarily recalling its Artificial Tears Lubricant Eye Drops, distributed to consumers as EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears, due to possible contamination.
The Centers for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of infections possibly linked to the use of the artificial tears manufactured by the Chennai-based firm, which was alleged to have breached manufacturing standards.
The alleged contamination involves “carbapenem-resistant Pseudomonas aeruginosa”, a rare strain of extensively drug-resistant bacteria.
“The FDA recommended this 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,” the FDA stated.
“FDA is collaborating with the CDC and state and local health departments to investigate a multistate outbreak involving a rare, extensively drug-resistant strain of Pseudomonas aeruginosa bacteria. As of January 31, 2023, CDC identified 55 patients in 12 states with infections that have been linked by epidemiologic and laboratory evidence to use of EzriCare Artificial Tears.
“Associated adverse events include hospitalisation, one death with bloodstream infection, and permanent vision loss from eye infections.”
The FDA also placed Global Pharma Healthcare on import alert “for providing an inadequate response to a records request” and for not complying with CGMP requirements. The import alert prevents these products from entering the US.
“Global Pharma Healthcare is notifying the distributors of this product, Aru Pharma Inc. and Delsam Pharma and is requesting that wholesalers, retailers and customers who have the recalled product should stop use.”
Global Pharma Healthcare says it has provided a wide range of pharmaceutical formulations in several therapeutic forms to markets in Southeast Asia, Central America, LATAM, CIS, and Africa for more than two decades. It manufacturers products for 17 therapeutic areas, including eyecare.
The company posted the recall to the homepage of its website, stating that “this recall is being conducted with the knowledge of the U.S. Food and Drug Administration”.
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