FDA Reports Sterilization Issues in EzriCare Factory: Bacterial Contamination in Artificial Tears Products
Earlier this year, the US Center for Disease Control and Prevention (“CDC”) spotted an outbreak of a rare bacterial infection in 11 (now 16) different states, associated with multiple different infection types, particularly eye infections. Following epidemiology and laboratory evidence, the CDC was able to link these infections to the use of EzriCare Artificial Tears and found that Patient outcomes included permanent vision loss resulting from ocular infection, hospitalization, and death of one patient with bloodstream infection.
The Food and Drug Administration (“FDA”) followed by immediately warning consumers and health practitioners of a bacterial contamination involving EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears as they were manufactured by the same pharmaceutical company, Global Pharma Healthcare Private Limited, located in India.
The FDA also added a subsequent warning involving yet another over-the-counter product manufactured by Global Pharma Healthcare Private Limited, Delsam Pharma’s Artificial Eye Ointment, also due to potential contamination with the same bacterial strain. As of April 7, 2023, the FDA has identified 68 patients of a new strain of Pseudomonas aeruginosa in 16 states, including three patients dying, four others having had surgical removal of the eyeball, and eight patients having lost vision in at least one of their eyes. Some have had to undergo corneal transplants.
About the Bacteria Affecting the Recalled Products
Both recalled over-the-counter artificial tears have been found to carry this harmful and potentially deadly bacteria, which has proven to be resistant to most antibiotics. To make matters worse, scientists have known for decades that when this bacteria is introduced into the eye, it can have devastating effects of infection including corneal ulcers that spread rapidly, which can become necrotic causing blindness and may even necessitate the surgical removal of the entire eyeball. While the Pseudomonas aeruginosa bacteria have been around for years and may have previously responded to ordinary therapy, this particular strain, identified as part of the Center for Disease Control’s (“CDC”) investigation, has never been reported in the United States prior to this outbreak. This strain is particularly dangerous because it has evolved to increase its drug resistance over time and as reported by the CDC, appears to resist common antibiotics such as cefepime, ceftazidime, piperacillin-tazobactam, aztreonam, carbapenems, ceftazidime-avibactam, ceftolozane-tazobactam, fluoroquinolones, polymyxins, amikacin, gentamicin, and tobramycin. This particular bacterial strain has been detected in opened bottles of EzriCare drops collected from infected patients.
Due to the alarming reports of cases, FDA officials are also testing unopened bottles of the drops and eye ointments manufactured by the same company. All imports of these products have also been stopped by the FDA.
The FDA’s Inspection Report
Just last week, the Food and Drug Administration released its inspection report of Global Pharma’s plant in India where it was believed that the contamination occurred. The inspection of the Indian facility took place in late February through early March 2023. Among the most notable problems identified, the report sets forth:
- The facility lacked adequate validation of its sterilization processes to prevent microbiological contamination
- The facility used below-industry-standard filtration testing
- The facility failed to perform container closure testing to ensure product protection had not been compromised or adulterated
- The facility used deficient manufacturing processes that lack product sterility assurance to manufactured products
- Drug production and control records were not properly reviewed by the facilities’ quality control unit to ensure compliance
Global Pharma products were shipped to the U.S. between December 2020 and April 2022. In summary, these preliminary findings noted serious deficiencies in the formulation of the company’s products, particularly of their eye drop and eye ointment products which did not contain preservatives to prevent microbial contamination, and deficiencies in cleaning, sterilizing, testing, and quality control.
Consumer Safety Needs to Be a Top Priority
As a result, it is not surprising the FDA’s preliminary findings raise serious questions about this company’s sterilization practices and their knowing disregard for the safety of U.S. consumers.
While preservation-free artificial tears are an important treatment for individuals who suffer from chronic dry eyes and who rely on their use several times per day, if these products are not properly packaged, then they are more prone to bacterial contamination. This is why it is common for these products to be packed for single-use and not in multiple-use bottles.
Companies in this industry control the risks of bacterial contamination, yet the Ezricare and Delsam Pharma’s Artificial Tears that have been recalled were packaged in multiple-use bottles and not in single-use disposable containers. Dr. Vicente Diaz, the chief of ophthalmology at Yale Health Plan in Connecticut, specializing in infectious diseases, recently shared his concerns with the New York Times. Dr. Diaz discussed how this over-the-counter preservative-free eye drop formulation could be allowed to go on the market without more scrutiny, concluding that this was “like the perfect storm.”
While it is early to rule out other factors that may have led to this multistate outbreak of a drug-resistant bacteria, the FDA inspection report documenting issues with cleaning, sanitizing, decontaminating, and sterilizing – in addition to other failures in maintaining good manufacturing processes – at Global Pharma’s India facility surely warrants additional investigation. More information on the FDA’s preliminary findings will likely come out soon as the agency wraps up its investigation and issues a formal report and warning letter to the company. Regardless, though, it seems clear the manufacturing process did not place sufficient importance on sterile manufacturing practices or on the decision to package multiple containers.
Regulatory Updates Need to Be Made
This recent bacteria outbreak in a pharmaceutical product highlights regulatory gaps in controlling imports of overseas medications and the impact on U.S. consumers. The FDA has confirmed prior to their recent inspection and despite FDA previous warnings of unsanitary conditions to other companies, the FDA had not inspected this facility since the company first began exporting their products into the United States. While the FDA is required to conduct a pre-approval inspection of plants that manufacture prescription drugs, there is no such mandate for those that make over-the-counter medicines like artificial tears. Given the importance of sanitary production because of the nature of the product, we should be able to expect manufacturers like Global Pharma should pay close attention to sanitary, decontamination and sterilizing standards that could have prevented this terrible bacterial outbreak. The need for compliance testing of drug manufacturing facilities should be a universal standard and our regulatory agencies need to make testing of these facilities a priority if they intend to enter the U.S. market.
What Should Consumers Do Now?
The CDC has asked users of these eye products to immediately stop using EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears or eye ointment and to seek medical care if having signs or symptoms of eye infection, including:
- Yellow, green, or clear discharge from the eye
- Eye pain or discomfort
- Redness of the eye or eyelid
- A feeling of something in your eye (foreign body sensation)
- Increased sensitivity to light
- Blurry vision
Our lawyers have been pioneers in several nationwide eye product cases and have experience fighting eyedrop manufacturers whose products contain defective components that cause infections. We have litigated cases involving contaminated products and eye solutions with component defects that defeated their ability to protect the eye from infections. We are ready to use our experience to help those injured by these contaminated products.
Contact Our Mass Tort Attorneys Today to Discuss Your Legal Options
If you would like to discuss the facts of your use of this product, contact mass tort attorneys Cal Warriner, Katie Kiziah, or Victoria Mesa-Estrada at Searcy Denney today at (800) 780-8607.