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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Manufacturer
- Biomic Sciences, LLC dba ION Intelligence of Nature
- Category
- Drug — Nasal spray
- Hazard
- microbial-contamination
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.
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