ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence of Nature Charlottesville, VA
Summary
The FDA issued a Class II for ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Int by Biomic Sciences, LLC dba ION Intelligence of Nature. Reason: Microbial contamination of Non-Sterile Products.
Details
Source
Drug Recall
External ID
D-0068-2024
Action Date
2023-11-01
Status
Terminated
Category
drug
Product Description
ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* Intelligence of Nature 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 II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
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 II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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-0068-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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