Indian firm recalls eye drops after US flags 55 cases of adverse events, including one death
The ‘Artificial Tears’ eye drop manufactured by Tamil Nadu-based Global Pharma Healthcare was under inquiry in 12 states of the US since May.
Following an alert issued by the Centers for Disease Control and Prevention to the US Food and Drug Administration about 55 cases of adverse events related to an eye drop imported from India, Tamil Nadu based-manufacturer Global Pharma Healthcare on Friday announced an immediate recall of its product named “Artificial Tears”.
The company has asked all retailers and wholesalers in the US to return the batch of the eye drop found to be contaminated.
“To date, there are 55 reports of adverse events including eye infections, permanent loss of vision, and a death with a bloodstream infection,” Global Pharma Healthcare said in its recall order, citing the Centers for Disease Control and Prevention.
Global Pharma’s manufacturing unit is located in Alathur town of Kanchipuram district in Tamil Nadu. The company manufactures ointments, liquid oral formulations, tablets and exports them to more than 30 countries.
The company did not respond to an email from Scroll.
PV Vijayalakshmi, the drug controller of Tamil Nadu, told Scroll that an investigation into the manufacturing plant started on Friday.
“We received the information through official channels,” said Vijayalakshmi. “Our team is inspecting the manufacturing unit right now.” She added that they were collecting information about the product and whether it has also been sold in India, or exported to any other country.
“So far we have been told this product was exported,” she said.
In a multi-state inquiry in the US, the Centers for Disease Control and Prevention linked the eye drop with a bacterial infection that affects the blood and lungs by causing pneumonia, and is resistant to an antibiotic called carpabenem. Resistance to this antibiotic, often used to treat severe bacterial infections, increases chances of fatality.
The Centers for Disease Control and Prevention had collected samples from patients between May 2022 and January 2023. Patients who used the eye drop suffered from inflammation in the cornea, infection in the eyeball, respiratory infection, urinary tract infection, and sepsis. Several patients suffered permanent vision loss.
On February 1, the Centers for Disease Control and Prevention issued an alert stating that the eye drops had been packaged under the name “EzriCare” and so far 12 states have reported 55 patients who purchased the eye drop over the counter.
“CDC laboratory testing identified the presence of the outbreak strain in opened EzriCare [Artificial Tears] bottles with different lot numbers collected from two states,” the disease control body said.
It added that the bacterial contamination could have occurred during the use of eye drops or during the manufacturing stage. “Testing of unopened bottles of EzriCare Artificial Tears is ongoing to assist in evaluating for whether contamination may have occurred during manufacturing,” the alert said.
The eye drop in question was sold in 15 ml bottles and used to relieve eye irritation and dryness in the eye. Most of the bottles were sold over the internet via two distributors, Delsam Pharma, that packages and labels the eye drop as Delsam Pharma’s Artificial Tears, and Aru Pharma, that has labelled the product as EzriCare Artificial Tears. Patients reported eye infection, discharge from the eye, pain, redness in eye and eyelid, blurry vision and several required hospitalisation.
Kuppusamy Arumugam, from US-based distributor Delsam Pharma, said the eye drops relabelled and sold by them are not included in the CDC complaints. “We had a safety seal on our product bottle. We were not associated with EzriCare and did not purchase the product from the manufacturer at the same time,” Arumugam said in an email reply.
Since October last year, this is the third Indian pharmaceutical company linked with mass casualties or adverse events in other countries.
In October, the World Health Organisation issued a medical alert against four cough syrups manufactured by Haryana based Maiden Pharmaceuticals after linking it with death of 70 children in Gambia.
In January, Uzbekistan government issued an alert against Marion Biotech, a Uttar Pradesh based company, after finding contamination in anti cold syrups that led to death of 18 people. Both countries claimed to have found diethylene glycol and ethylene glycol in the syrups. The two impurities are fatal and can attack the nervous system.