The Central Drugs Standards Control Organisation (CDSCO), the country’s drug regulator, has sent a team of experts to inspect Chennai-based manufacturer Global Pharma Healthcare after the US Food and Drug Administration (FDA) restricted the import of eye drops manufactured by the company. The FDA said the company’s Artificial Tears brand of eyedrops were linked to multiple adverse events. “To date, there are 55 reports of adverse events, including eye infections, permanent loss of vision and a death with a bloodstream infection”, the FDA said in a statement. The company has voluntarily recalled all the lots of the eyedrop due to possible contamination, the FDA said.
Experts from DGCI are inspecting Global Pharma Healthcare’s production facilities, and samples will be taken for further investigation, ET has been told by people aware of the developments.
The products are not sold in India, the same people said.
Global Pharma Healthcare said it is notifying distributors Aru Pharma Inc and Delsam Pharma, and requesting wholesalers and retailers to recall the product. Customers who have the purchased the product should stop using it, the company said in a statement. This recall is being conducted with the knowledge of the US Food and Drug Administration, it further said.
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