ION*Sinus Spray recalled over sterility concerns

Recall date

September 29, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Biomic Sciences, LLC dba ION Intelligence of Nature recalls ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA

Recall number

D-0067-2024

FDA classification

Class I

Brand / firm

Biomic Sciences, LLC dba ION Intelligence of Nature

Sold / distributed

Nationwide in the United States and to Canada, New Zealand, Australia, Indonesia, Malaysia, Great Britain, and the Netherlands

Why it was recalled

Microbial contamination of Non-Sterile Products

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA