Post Update (5/2/23)
The FDA recently issued citations to Global Pharma Healthcare Ltd. after the first visit to their artificial tear drop processing plant. They identified dirty equipment and surfaces that prepared products “were not cleaned, sanitized, decontaminated or sterilized,” according to the citation document.
“You [Global Pharma] used a manufacturing process that lacked assurance of product sterility,” the FDA stated.
Other safeguards apparently were not taken and records about cleaning filling machines and spaces had gaps and discrepancies. One of the machines used to fill eye drop solution into bottles had a “black, brown greasy deposit” on one of its parts, though company logs said the machine had been cleaned weeks before.
“Your firm [Global Pharma] failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals,” the inspectors stated within the citation document.
The FDA did not say whether the strain of bacteria found in unopened bottles during the visit was the same as the strain mentioned below.
Table of Contents
What are artificial tears used for?
Artificial tears or eye drops are a liquid solution applied directly on the surface of the eye. They are used to relieve irritated or dry eyes. Some of the most common causes of dry or irritated eyes are allergies, prolonged sun exposure, windy weather, air pollution, prolonged computer use or reading on the computer, as well as autoimmune diseases and other illnesses.
Which Artificial Eye Drops are being Recalled?
In February, the Food and Drug Administration (FDA) issued a series of recalls warning against purchasing and using the following over-the-counter and prescription eye drop products:
- Global Pharma Healthcare Brand
- EzriCare Artificial Tears
- Delsam Pharma’s Artificial Tears
- Delsam Pharma’s Artificial Eye Ointment
- Apotex Corp.
- Pharmedica USA LLC
The FDA recommended the recall of these products due to bacterial contamination or non-sterility that may have been caused from a lack of appropriate microbial testing, inadequate sanitation for their bottles, poor packaging materials or lack of proper controls concerning tamper-evident packaging. Most of the affected products are packaged in a white aluminum tube or bottle within a paper carton and were distributed throughout the United States.
In addition, the FDA is also working with the Centers for Disease Control and Prevention (CDC) to monitor a potential bacterial outbreak associated with the recalls. The bacteria Pseudomonas aeruginosa is extremely drug resistant and harmful to the human body.
According to the FDA:
“As of January 31, 2023, CDC identified 55 patients in 12 states with infections that have been linked by epidemiologic and laboratory evidence to the use of EzriCare Artificial Tears.”
Resistant bacterial infections are difficult, and at times, impossible to treat. Eye-care professionals may try stronger medications than antibiotics to treat urgent infection cases, however, toxicity becomes a major risk. In rare cases, the complete removal of the infected tissue is needed.
As of now, the FDA has not highlighted any violations of good manufacturing practices by Apotex or Pharmedica, unlike with Global Pharma Healthcare . As a result, the two domestic manufacturers will not face the same restrictions as Global Pharma Healthcare, a company which is based in India.
What are the side effects of a bacterial contamination?
According to the FDA, some of the victims of the eye drop contamination have suffered bloodstream infections and vision loss from eye infections, which for some, have led to permanent blindness. According to Pharmanews Intelligence, the Pseudomonas aeruginosa bacteria has “contributed to one patient’s death.”
How to tell if your Eye Drops are contaminated
There are several signs you can look for to tell if your eye drop or artificial tears product is contaminated:
- You notice a change in eye droplet color
- You notice a change in consistency of the eye drop
- You notice a poor odor coming from the bottle
What are the signs of an eye infection?
Some common signs of an eye infection may include:
- A yellow, green or clear discharge from the eye
- Eye pain or discomfort
- Redness
- The feeling that something is in the eye
- Increased sensitivity to light
- Blurry vision
If you believe you may have an eye infection, you can seek a professional to administer an eye exam. They would be able to determine if it’s bacterial and the degree of severity of the infection.
Have you been exposed to contaminated artificial tear drops?
At Fleming, Nolen & Jez, our product liability lawyers have dedicated their careers to fighting for the rights of injured victims throughout the United States. If you were seriously injured from using artificial eye drops that were contaminated due to a manufacturer’s negligence, you may be able to file a lawsuit to secure the compensation you deserve. Contact us today to speak with a member of our legal team to review your case information.
