After the investigation ended at 2 am, authorities ordered the manufacturer to stop making ophthalmic solutions.
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In response to US authorities flagging a Chennai-based pharmaceutical company for fatal contamination in eye drops, Tamil Nadu’s Drug Controller and the Central Drug Control Authority inspected Global Pharma Healthcare Private Limited late at night. About 40 km south of Chennai, the pharma company voluntarily recalled its artificial tears lubricant eye drops after the country’s health protection agency said they could be contaminated with drug-resistant bacteria that have caused 55 adverse events, including permanent vision loss and one death.
Dr P V Vijayalakshmi, the Drug Controller of Tamil Nadu, told NDTV, “We’ve collected samples from batches sent to the US, along with raw materials used. I’ve filed a preliminary report.”
As a result of the investigation, the manufacturer has been ordered to stop making ophthalmic solutions. Adding that the plant has a valid license to manufacture and export the product, Dr Vijayalakshmi said the investigation would proceed once they get US investigation reports on the unopened samples. “They’ve only looked at opened samples from hospitals,” she said.
Global Pharma Healthcare, the drug maker at the center of the controversy, says it works closely with the FDA. Consumers in the US were also advised to stop using the product, and those experiencing adverse effects were told to seek medical attention immediately, besides reporting on its portal or phone help lines.
The US Centers for Disease Control and Prevention (CDC) are testing unopened bottles of EzriCare Artificial Tears eye drops, manufactured by Global Pharma Healthcare. The FDA has restricted imports of the company’s products.
Earlier, Global Pharma Healthcare had said it was voluntarily recalling all lots within expiration of its Artificial Tears Lubricant Eye Drops, distributed by EzriCare, LLC, and Delsam Pharma, to consumers.
A nationwide outbreak of Pseudomonas aeruginosa has sickened at least 55 people across a dozen states, causing at least one death, CBS News reported.
According to the network, five of the 11 patients who had infections directly in their eyes have lost their vision so far.
In recent years, antibiotic resistance has made it harder to treat Pseudomonas aeruginosa infections in the blood, lungs, and wounds.
After dozens of deaths linked to cough syrups last year in the Gambia and Uzbekistan, an India-made brand of eye drops is under scrutiny.
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