ION Sinus Support Nasal Spray Recalled for Microbial Contamination
Biomic Sciences is recalling all lots of ION Sinus Support Nasal Spray due to microbial contamination. The product has been distributed nationwide and internationally.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for microbial contamination of a nasal spray product. The product represents a risk of harm due to potential microbial infection via the nasal and respiratory route. No illnesses or deaths have been reported in the source, which limits the severity to High rather than Severe.
Plain-English summary
Biomic Sciences, LLC (dba ION Intelligence of Nature) is recalling all lots of ION Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, due to microbial contamination. The product is manufactured by ION Intelligence of Nature in Charlottesville, VA.
The affected product has been distributed nationwide in the United States and internationally to Canada, New Zealand, Australia, Indonesia, Malaysia, Great Britain, and the Netherlands. All lots within expiration are included in this Class II recall.
The recalled product
- Product
- ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence of Nature 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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