Samples of eye drops linked to blindness, deaths in US 'free of contamination,' official sources clarify
New Delhi, April 4: The samples of eye drops manufactured by India's Global Pharma Healthcare linked to three deaths and blindness in some patients in the US, are found to be "free of contamination", Health Ministry sources informed on Tuesday.
According to Health Ministry sources, the US Food and Drug Administration of the United States (US FDA) India has discovered samples examined at a Bengaluru facility to be "free of any contamination." According to the source, "Indian samples tested were found to be of standard quality. We found the samples free of any contamination."
The Drug Controller General of India (DCGI) has also formally submitted a letter to the USFDA, though the USFDA has yet to respond.
A joint inspection was also conducted today at the manufacturing unit by the Central Drugs Standard Control Organization (CDSCO) and Tamil Nadu state drugs inspectors, and production has been halted till the probe is completed.
Previously, in February, the USFDA advised customers not to buy or use EzriCare Artificial Tears owing to probable contamination. Using contaminated artificial tears raises the risk of eye infections, which can lead to blindness or death.
Global Pharma initiated a voluntary recall of all unexpired lots of EzriCare Artificial Tears and all unexpired lots of Delsam Pharma's Artificial Tears at the consumer level.
Following the FDA warning in February, a group of drug inspectors from the Central and Tamil Nadu governments performed an inspection at the company's facility, which is 40 kilometres south of Chennai.
- PTC NEWS
