ION Sinus Spray recalled nationwide for microbial contamination
The FDA has recalled ION Sinus Spray due to microbial contamination of the non-sterile product. All lots are affected regardless of expiration date.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recalls receive a minimum severity score of 4 per the rubric. No illnesses, injuries, or deaths are reported in the source material, so the score reflects the agency's own Class I classification.
Plain-English summary
The FDA is recalling ION Sinus Spray (1 fl oz/30 mL), manufactured by Biomic Sciences, LLC dba ION Intelligence of Nature, due to microbial contamination.
All lots of the product currently in distribution are affected, regardless of expiration date. The product was distributed nationwide in the United States and internationally, including Canada, New Zealand, Australia, Indonesia, Malaysia, Great Britain, and the Netherlands.
Consumers who have purchased this product should stop using it and contact their healthcare provider with any questions or concerns about their use of the product.
The recalled product
- Product
- ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA
- Category
- Drug — Nasal spray
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Biomic Sciences, LLC dba ION Intelligence of Nature under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Biomic Sciences, LLC dba ION Intelligence of Nature
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