Nasal Spray Recall 2021: Yeast Contamination Could Cause Fungal Infection

A company is voluntarily recalling one lot of its nasal spray as the product is contaminated with yeast. People with compromised immune systems are more at risk of developing an invasive fungal infection (IFI) if they use the contaminated product.

NDAL MFG's Manukaguard Allercleanse is a manuka honey spray that's used to clean nasal passages and sinuses from irritants or contaminants such as bed mites and pet dander. The company found that one lot of the product was contaminated with yeast.

The affected nasal spray (lot number 2010045) could cause adverse health events that require "medical or surgical intervention" if they were used by children, adults and the elderly, the company said on the Food and Drug Administration (FDA) website. If it is used by people who are immunocompromised, the contaminated product may even cause "life threatening" IFI.

So far, the company has not received any reports of adverse reactions related to the recall.

Manukaguard Allercleanse was distributed nationwide and was also sold online on Amazon. Customers should stop using the affected product. If someone is having health problems after using the product, they should contact their healthcare provider and also report it to the FDA.

What is IFI?

Fungi are a group of micro-organisms that are not plants or animals. Just around 300 of the 1.5 million fungi species found on the planet are known to cause illness in people. However, some "opportunistic" fungal infections can be quite aggressive and spread quickly to the organs, Leadiant Biosciences explained.

According to Leading International Fungal Education (LIFE), IFIs are generally uncommon in people with normal immune systems. It is the patients who are immunocompromised who are more at risk. This includes those undergoing chemotherapy, patients taking immunosuppressants and those with immune deficiency conditions.

The most common IFIs are candidaemia and invasive candidiasis as well as cryptococcosis. Candidaemia, for instance, has a mortality of 30 to 55%. The doctors' experience and quick diagnostic testing are key in determining IFI survival, LIFE noted.