Eye drops made in Chennai by Global Pharma Healthcare and linked to at least three deaths and blindness in some patients in the United States have been found to have ‘no contamination’, news agency Reuters said Tuesday referring to a report by broadcaster NDTV that cited union health ministry sources as saying tests showed samples of the eye drops were of ‘standard quality’.
This comes days after the US’ Food and Drug Administration said the Chennai-based firm was recalling 50,000 tubes of the lubricant due to ‘bacterial contamination’. News agency PTI quoted a report by the FDA as saying ‘…analysis found unopened tubes to be contaminated with bacteria’.
The company initiated a voluntary Class I recall – for artificial tear drops used to protect against irritation or to relieve dryness of the eye – on February 24.
READ | Chennai-based firm’s eye drops linked to vision loss and death in US
FDA regulations say a Class I recall is the most urgent and is usually reserved for defective products that can cause serious health problems.
Last month Bloomberg reported that the FDA had asked patients in the United States to immediately stop using the product after over 50 reports of ‘adverse events’ including eye infections and permanent vision loss.
At that time one death had been linked to use of the eye drops.
“… warning consumers and health care practitioners (to) immediately stop using EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination. Using contaminated artificial tears increases risk of eye infections that could result in blindness or death,” the FDA said.
READ | Chennai-based drug firm recalls eye drop linked to vision loss in US
Patients presented with a variety of conditions – from eye infections to blood poisoning, often called sepsis, the US’ Centers for Disease Control and Prevention said. The infections are caused by a rare strain of Pseudomonas aeruginosa bacteria that is resistant to many commonly used antibiotics and had not been previously seen in the United States, the CDC further said.
The FDA action prompted an investigation by Tamil Nadu’s Drug Controller and Central Drug Control Authority, which conducted a late-night inspect of the manufacturing premises and took samples.
READ | Tamil Nadu firm told to suspend eye drops’ manufacturing
Meanwhile, in a separate disclosure, the FDA said Mumbai-based Sun Pharma is recalling 1,920 bottles of Dofetilide capsules used to treat irregular heartbeats.
Sun Pharma’s US unit initiated the recall over ‘failed content uniformity specifications’, the FDA report said. The firm initiated a Class III recall – used in a ‘situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences’ – on March 9.
With input from agencies
