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Following the recall of EzriCare and Delsam Pharma Artificial Tears eye drops due to contamination concerns, the U.S. Food and Drug Administration (FDA) inspected the manufacturing facility in India where the products are made.

A recently released report details the agency’s findings, which include multiple failures in quality control and sterility assurance.

Global Pharma Recalls EzriCare, Delsam Pharma Eye Drops and Ointment

Back in January 2023, the FDA and the U.S. Centers for Disease Control and Prevention (CDC) warned the public about an outbreak of antibiotic-resistant infections, most affecting the eyes. Investigators found that the majority of the patients had used EzriCare Artificial Tears before being diagnosed, and later found the same type of antibiotic-resistant bacteria in opened bottles of EzriCare.

Since then, the number of infection cases has climbed, affecting 68 patients across 16 states. Officials have identified the bacteria as a rare strain of extensively drug-resistant P. aeruginosa. Three people have died and there have been 8 reports of vision loss and 4 reports of enucleation (surgical removal of eyeball).

On February 2, 2023, Global Pharma—the company in India that manufactures the eye drops—initiated a recall of all lots of their artificial tears products distributed by EzriCare and Delsam Pharma. On February 24, 2023, the company also recalled batch no. H29 of the artificial eye ointment distributed by Delsam Pharma, also due to possible microbial contamination.

All of the recalled products were produced at the same Global Pharma Healthcare plant in India, so the FDA inspected the facilities there starting in late February.

Inspectors Find Multiple Failures at Eye Drops Manufacturing Plant

According to the investigation report, Global Pharma was not taking the appropriate steps to ensure that its products were sterile and safe for public use.

Investigators found the following issues, among others:

  • Failure to validate the sterilization process. Investigators noted that “there is not adequate validation data to demonstrate” that the filtration process used reliably sterilizes the product solutions.
  • Failure to establish that the sterilization is effective across different manufacturing conditions.
  • Failure to properly validate or document filter integrity tests conducted at the facility.
  • The manufacturing process used to produce the artificial tears and ointment products was deficient and lacked assurance of product sterility.
  • Unqualified visual inspectors examined the filled units after incubation.
  • The equipment used to manufacture, process, pack, or hold the products was not designed appropriately for its intended use.
  • Cleaning and disinfecting of the rooms where the products were produced were inadequate, as was cleaning of certain surfaces, containers, tools, and garments used by employees.

Individuals Who Were Hurt Deserve Justice

Many individuals who used EzriCare and Delsam Pharma eye drops and eye ointments and then suffered from difficult and damaging infections have filed lawsuits against the manufacturers and distributors. Some have suffered from permanent injuries to their eyes along with destructive vision loss.

It is expected that the number of cases filed will increase as more people become aware of the potential health problems that are related to the use of these eye products.

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