Midnight inspection at Chennai firm linked to vision loss, death in US
1 min read . Updated: 04 Feb 2023, 12:07 PM IST
Premium- US regulator Food and Drug Administration warned consumers ‘not to purchase or use EzriCare Artificial Tears’
- An unprecedented outbreak of Pseudomonas aeruginosa has occured in the US, affecting at least 55 people across a dozen states
Tamil Nadu's Drug Controller and Central Drug Control Authority conducted an inspection during midnight on Saturday at a Chennai-based pharmaceutical firm after US authorities flagged an issue regarding contaminated eye drops.
On Friday, the US regulator Food and Drug Administration warned consumers "not to purchase or use EzriCare Artificial Tears due to potential contamination". Besides, the US FDA has restricted the imports of products manufactured by Global Pharma Private Healthcare Limited.
In its warning to consumers, the FDA asked healthcare practitioners not to purchase and immediately stop using EzriCare Artificial Tears or Delsam Pharma's Artificial Tears due to potential bacterial contamination. Using contaminated artificial tears increases the risk of eye infections that could result in blindness or death.
Consequently, Global Pharma, located 40 km south of Chennai, has initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharma's Artificial Tears.
According to NDTV, Dr P V Vijayalakshmi, the Drug Controller of Tamil Nadu said they have collected samples from the batches sent to the US. " We are awaiting unopened samples from the US. I've filed a preliminary report to the government".
The inspection by the drug controllers was concluded at 2 am and authorities have ordered the suspension of the production of ophthalmic solutions by the manufacturer.
An unprecedented outbreak of Pseudomonas aeruginosa has occured in the US, affecting at least 55 people across a dozen states, and at least one death.
So far, 5 of the 11 patients who have had infections directly in their eyes have lost their vision, CDC reported.
Pseudomonas aeruginosa can cause infections in the blood, lungs, or wounds.
The India-made pharmaceutical brand is the latest to land under scrutiny after dozens of deaths among children in the Gambia and Uzbekistan last year linked to cough syrups.
