Sinus Spray Under Class I Recall

Microbial contamination has prompted a Class I recall of all lots of ION* Sinus Spray, according to the November 1, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recalling firm, Biomic Sciences of Charlottesville, Virginia, announced FDA testing identified Microbacterium sp, Fictibacillus sp, Bacillus sp, (primarily B malikii), and Paenibacillus sp.

The FDA’s most serious recall classification, a Class I designation warns use of the affected product could cause serious adverse health consequences or death.

“In the population most at risk, patients or individuals who recently underwent nasal or sinus surgery, there is a reasonable probability that the use of the affected product could potentially result in severe or life-threatening adverse events such as bacteremia or fungemia, invasive bacterial or fungal rhinosinusitis, or disseminated fungal infection,” Biomic Sciences said in a September 29, 2023, statement. “To date, Biomic Sciences has not received any reports of adverse events related to this product.”

The recall affects all lots of ION* Sinus Spray (1 fl oz/ 30 mL). The spray was distributed to wholesalers, retailers, and consumers throughout the US and in Canada, New Zealand, Australia, Indonesia, Malaysia, Great Britain, and the Netherlands between September 2019 and September 2021. The product was manufactured by ION* Biome, Charlottesville, Virginia.

Biomic Sciences, which does business as ION Intelligence of Nature, voluntarily initiated the recall September 29, 2023. On October 24, 2023, the FDA issued its Class I designation.

ION* Sinus Spray is an over-the-counter nasal rinse.