Biomic Sciences is recalling all lots of ION Sinus Support, ION Biome Sinus, and Restore Sinus Spray products because FDA testing found the product to contain microbial contamination identified as Microbacterium sp., Fictibacillus sp., Bacillus sp., (primarily B. malikii), and Paenibacillus sp. (these microorganisms are generally non-pathogenic).
Risk Statement: In the population most at risk, patients or individuals who recently underwent nasal or sinus surgery, there is a reasonable probability that the use of the affected product could potentially result in severe or life-threatening adverse events such as bacteremia or fungemia, invasive bacterial or fungal rhinosinusitis, or disseminated fungal infection.
To date, Biomic Sciences has not received any reports of adverse events related to this product.
BACKGROUND:
The product being recalled is used as a nasal rinse and is packaged in individual boxes of one or two nasal spray dispensers.
RECOMMENDATIONS:
- Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
- Consumers and other parties that have the recalled product should stop using the product and either discard it or take a photo of the lot number on the bottom of the bottle before discarding it and provide that to Biomic Sciences to arrange a refund (contact information provided in the recall).
- Parties with questions about this recall can contact the company.
Health professionals, patients and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
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