ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA
Summary
The FDA issued a Class I for ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA by Biomic Sciences, LLC dba ION Intelligence of Nature. Reason: Microbial contamination of Non-Sterile Products.
Details
Source
Drug Recall
External ID
D-0067-2024
Action Date
2023-11-01
Status
Terminated
Category
drug
Product Description
ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA
Lot/Code Info: All lots within expiry.
Quantity Affected: N/A
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-29
Company
Charlottesville, VA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 46 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Biomic Sciences, LLC dba ION Intelligence of Nature has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Biomic Sciences, LLC dba ION Intelligence of Nature) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Biomic Sciences, LLC dba ION Intelligence of Nature have FDA actions?
Biomic Sciences, LLC dba ION Intelligence of Nature has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0067-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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