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The state and the Central drug regulators in the country has taken swift action against Global Pharma Healthcare, the Chennai-based pharma manufacturer which has initiated a voluntary recall in the United States of America after its lot ophthalmic drug reportedly resulted in adverse events including a death, by halting the production in its Tamil Nadu facility.
A team of drug control officials from the State and the Central Drugs Standard Control Organisation (CDSCO) conducted an inspection in the factory premises overnight immediately after the US Food and Drugs Administration (FDA) announced the voluntary recall. Based on the findings, the officials have asked the company to stop manufacturing in the facility, according to reports.
The company announcement was issued on February 2, following which on the same day the US FDA published the product recall announcement, due to potential microbial contamination.
“Global Pharma Healthcare 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,” said the US drug regulator’s announcement.
The Centers for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of Verona Integron-mediated Metallo-ß-lactamase (VIM)- and Guiana-Extended Spectrum-ß-Lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare.
Till February 2, there were 55 reports of adverse events including eye infections, permanent loss of vision, and a death with a bloodstream infection, it added.
Use of contaminated artificial tears can result in the risk of eye infections that could result in blindness.
Artificial tears (carboxymethylcellulose sodium) lubricant eye drops, 10 mg in 1 mL, ½ fl oz (15 ml) bottle are used as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun. The product was distributed nationwide in the USA over the Internet.
Global Pharma Healthcare has notified the distributors of this product, Aru Pharma Inc. and Delsam Pharma and has requested that wholesalers, retailers and customers who have the recalled product should stop use.
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