The agency said on Thursday that Artificial Tears eye drop manufactured by India’s Global Pharma Healthcare Pvt Ltd has a potential bacterial contamination and the company has violated current good manufacturing practices
The U.S. Food and Drug Administration (FDA) has warned against using an eye drop made in India that has been linked to the outbreak of a drug-resistant bacteria leading to adverse events in at least 55 patients in the United States including infections, blindness and one death.
The agency said on Thursday that Artificial Tears eye drop manufactured by India’s Global Pharma Healthcare Pvt Ltd has a potential bacterial contamination and the company has violated current good manufacturing practices.
After the US regulator Food and Drug Administration warned consumers “not to purchase or use EzriCare Artificial Tears due to potential contamination”, the Central Drugs Standard Control Organization (CDSCO) under the Union Health ministry and the Tamil Nadu State Drug Controller have initiated a probe into the pharma firm producing this eyedrop, a source aware of the issue said on Friday.
“Teams from CDSCO and TN State Drug Controller, comprising three officials, are on their way to the manufacturing plant located near Chennai. It’s a contract manufacturing plant supplying through others to the US market. This specific drug is not sold in India,” said the source.
FDA has also restricted the imports of products manufactured by Global Pharma Private Healthcare Limited.
“The import alert prevents these products from entering the United States,” FDA said in a statement, adding “FDA is warning consumers and health care 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.”
The over-the-counter products, manufactured by Global Pharma Healthcare Private Limited, are intended to be ‘sterile’, the FDA noted.
Global Pharma has initiated a voluntary recall at the consumer level of all unexpired lots of EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears, the source informed further.
FDA added that it recommended this recall due to the company’s current good manufacturing practice (CGMP) violations, including lack of appropriate microbial testing, formulation issues (the company manufactures and distributes ophthalmic drugs in multi-use bottles, without an adequate preservative), and lack of proper controls concerning tamper-evident packaging.
U.S. FDA says India-made eye drop linked to some infections, blindness and one death