FDA Eyedrop Recall: Global Pharma Failed To Properly Sanitize Products

• The Food and Drug Administration (FDA) found that Global Pharma Healthcare did not follow proper sterilization or cleaning procedures in its manufacturing facility
• The incident is believed to have caused an outbreak of bacterial infections
• Nearly 70 patients in 16 states have been infected with a "rare strain" of Pseudomonas aeruginosa as of March 14

The United States Food and Drug Administration (FDA) released a report that says Global Pharma Healthcare did not follow proper sterilization or cleaning procedures resulting in the company's eyedrops being linked to a deadly bacterial infection outbreak.

Last month, Federal inspectors finished their analysis of Global Pharma Healthcare's India facility, where the company was known to manufacture EzriCare and Delsam Pharma Artificial Tears products.

FDA Orders Recall on Global Pharma's Eyedrop Products

In February, these two products were recalled due to potential microbial contamination following a series of multi-state outbreaks of drug-resistant bacteria. The situation was being investigated by state and federal health officials.

Of the 70 known patients across 16 states infected with a "rare strain" of Pseudomonas aeruginosa, 37 were linked to four healthcare facility clusters. According to Fox Business, the Centers for Disease Control and Prevention (CDC) also reported that three people lost their lives due to the infections.

Officials added that eight patients were found to be suffering vision loss, and four other individuals had to get their eyeballs removed. One woman from Florida who had her eye removed in September last year also filed a lawsuit against the Global Pharma company, claiming that their product made her legally blind.

In the report of the FDA published on Friday, investigators said that Global Pharma used a manufacturing process but did not have an assurance of product sterility. Furthermore, officials argued that the company lacked a "clear and specific written procedure for aseptic interventions performed," referring to the state when something is contamination-free.

The FDA noted that Global Pharma did not monitor or have studies to show how often workers could reuse clothing. Investigators also found that the company's staff used booties at the manufacturing facility were "discolored" and "worn out."

Links to a Deadly Bacterial Infection Outbreak

The CDC noted that the deadly bacteria could spread among people who have not shown any symptoms and transfer over to individuals who have not used the eyedrops. It was said that this type of spread was particularly common in healthcare settings, according to CNN.

In an email on Monday, the health agency said that the bacteria could spread among patients when one touches common items or when healthcare workers carry the germs over. They argued that infection control, such as hand hygiene, was crucial in these settings.

Another worrisome finding that inspectors observed was a "black, brown greasy deposit" on one of the company's machines that were used to fill its product into bottles. Based on logs, workers claimed that the equipment was cleaned a few weeks beforehand and has yet to be used since, said CBS News.

Tags

FDA, Products, Bacterial infection