HQ Team
April 3, 2023: Global Pharma Healthcare, Chennai, India -based drug company, is voluntarily recalling its eye drops in the US. market due to possible contamination.
The Centers for Disease Control and Prevention (CDC) alerted FDA to an investigation on the bacteria called Pseudomonas aeruginosa.
There were 55 reports of adverse events, including eye infections, permanent loss of vision, and death with a bloodstream infection, according to a company statement.
The germ is commonly found in the environment, like in soil and water. The Pseudomonas bacteria, which most often causes infections in humans, can cause infections in the blood, lungs, or other body parts after surgery.
In the US, these bacteria are finding new ways to avoid the effects of the antibiotics used to treat the infections they cause.
Multi-drug resistant
Antibiotic resistance occurs when the germs, no longer respond to the antibiotics designed to kill them. If they develop resistance to several types of antibiotics, these germs can become multi-drug resistant.
The CDC issued a health alert in 12 states about infections with the extensively drug-resistant strain.
EzriCare LLC and Delsam Pharma distributed Global Pharma’s medicine in the US.
The infections were “possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare,” according to the statement.
Using contaminated artificial tears can result in the risk of eye infections that could result in blindness.
Exposure to wind, sun
Artificial tears lubricant eye drops in bottles are used as a protectant against irritation or to relieve dryness of the eye for the “temporary relief of discomfort” due to minor eye irritations or exposure to wind or sun.
The product is packaged in a bottle with a safety seal and is placed in a carton box by distributors. The medicine was distributed nationwide in the US online.
Global Pharma Healthcare has notified the distributors of this product and requested wholesalers, retailers, and customers to stop using them.
Most patients reported using artificial tears. Patients reported more than 10 different brands of artificial tears; some used multiple brands, according to a CDC statement.
Over-the-counter product
Most patients who used artificial tears reported using EzriCare Artificial Tears, a preservative-free, over-the-counter product packaged in multi-dose bottles.
The CDC laboratory testing identified the presence of the outbreak strain in opened EzriCare bottles with different lot numbers collected from two states.
“Patients and healthcare providers should immediately discontinue using EzriCare artificial tears pending additional guidance from CDC and the Food and Drug Administration (FDA),” according to the CDC statement.
The recall is being conducted with the knowledge of the US Food and Drug Administration, Global Pharma stated.
