FDA Recall D-0067-2024
Biomic Sciences, LLC dba ION Intelligence of Nature · Charlottesville, VA
Class I — life-threatening Terminated 285 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA
Reason for recall
Microbial contamination of Non-Sterile Products
Recall record
- Recall number
D-0067-2024- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide in the United States and to Canada, New Zealand, Australia, Indonesia, Malaysia, Great Britain, and the Netherlands
- Recall initiated
- 2023-09-29
- Classified by FDA Center
- 2023-10-24
- FDA published
- 2023-11-01
- Terminated
- 2024-07-10
- Recalling firm
- Biomic Sciences, LLC dba ION Intelligence of Nature
- Firm location
- Charlottesville, VA