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Indias Drug Regulatory Body Takes Action against Global Pharma following USFDA Warning

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Timsy Jaipuria    04 February 2023

The US FDA had raised concerns about the probable production of tainted eye drops at a contract manufacturing facility in Chennai that supplies EzriCare artificial tears, and the Indian drug controller acted swiftly to stop it.

 

According to the sources, teams from the State Drug Controller and the Central Drugs Standard Control Organization (CDSCO) are en route to a contract manufacturing facility that supplies the US market with EzriCare artificial tears through third parties.

 

Global Pharma Healthcare PVT Limited produces EzriCare artificial tears in India, while Aru Pharma Inc. imports them into the US. According to the warning issued by the US FDA, EzriCare artificial tears might be contaminated with bacteria, and the resultant infections can have serious effects like blindness or even death.

 

The maker of EzriCare Artificial Tears, Global Pharma Healthcare Private Limited, announced a voluntary recall of all batches that had not yet reached their expiration dates. As of January 31, 2023, the CDC has determined that diseases associated with the usage of EzriCare artificial tears have been contracted by 55 people across 12 US states. At present, consumers are being urged by the CDC to avoid using EzriCare artificial tears until the CDC and FDA give further instructions. 

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