FDA recall D-0069-2024

Biomic Sciences, LLC dba ION Intelligence of Nature · Class II · drug

Product

Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA

Reason for recall

Microbial contamination of Non-Sterile Products

Distribution

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

Key facts

Status
Terminated
Initiation date
2023-09-29
Report date
2023-11-01
Termination date
2024-07-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Charlottesville, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0069-2024