After its artificial tear lubricant eye drops were linked for possible contamination causing vision loss of five people and one death in the US, the Chennai-based Global Pharma Healthcare has voluntarily recalled its product sold under the brand name EzriCare.
This is the third Indian pharma company in the past few months whose pharmaceutical products have been allegedly found to be of substandard quality.
The move to recall came after the Centers for Disease Control and Prevention (CDC) urged people to immediately stop using the eye drops, which had possibly been contaminated with Pseudomonas aeruginosa, a type of bacterium resistant to most antibiotics.
The EzriCare artificial tears have been linked to at least 55 cases of bacterial infection in 12 States. Five of those people so far have had vision loss. One person died when the bacteria entered the bloodstream.
“The product was distributed nationwide in the USA over the internet,” Global Pharma Healthcare wrote in its announcement of the recall.
The drops are distributed by EzriCare and Delsam Pharma. EzriCare said in a statement on Wednesday that it “had no role in the formulation, packaging delivery system or actual manufacturing of this product.” The company said it only designed the label and marketed the product.
On Wednesday, the CDC said it is working with the Food and Drug Administration (FDA) and State and local health officials to investigate the outbreak. A majority of the patients reported using the eye drops before they became ill.
Cases have been reported in California, Colorado, Connecticut, Florida, New Jersey, New Mexico, New York, Nevada, Texas, Utah, Washington and Wisconsin, the CDC said, according to news reports.
The CDC investigators found the bacteria in bottles of the eye drops, and are now doing tests to determine whether it matches the strain found in patients. It is unclear whether the contamination occurred during the manufacturing process, or when bottles were opened by consumers. Pseudomonas aeruginosa bacteria can be found on the hands of otherwise healthy people.
The FDA cited multiple violations of manufacturing regulations by the company, including a “lack of appropriate microbial testing” and a “lack of proper controls concerning tamper-evident packaging.”
“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 risk of eye infections that could result in blindness or death,” the agency said in a statement Thursday.
According to the CDC, symptoms of an eye infection included, yellow, green or clear discharge from the eye, eye pain or discomfort, redness of the eye or eyelid, feeling foreign body sensation, increased sensitivity to light and blurry vision.
Last month, 20 children in Uzbekistan died, reportedly after consuming cough syrup marketed by Noida-based Marion Biotech. Before that in October last year, 66 deaths in Gambia were linked to the consumption of cough syrups from the Indian company Maiden Pharmaceuticals.
