Contaminated Nasal Rinse Recalled

Biomic Sciences, which does business as ION Intelligence of Nature, recalls Restore Sinus Spray due to potential microbial contamination. The recall was published in the November 1, 2023, US Food and Drug Administration (FDA) Enforcement Report.

According to Biomic Sciences, the FDA found Microbacterium sp, Fictibacillus sp, Bacillus sp, (primarily B malikii), and Paenibacillus sp in the product.

The recall affects all lots of Restore Sinus Spray. 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 June 2017 and September 2019. The product was manufactured by Biomic Sciences, Charlottesville, Virginia.

Biomic Sciences voluntarily initiated the recall September 29, 2023. On October 24, 2023, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Restore Sinus Spray is an over-the-counter nasal rinse.