The company Biomic Sciences is voluntarily recalling ION* Sinus Support, ION* Biome Sinus, and Restore Sinus Spray products due to microbial contamination.
The Virginia-based company said that it was recalling the products after testing by the Food and Drug Administration found they contained microbial contamination, identified as Microbacterium sp., Fictibacillus sp., Bacillus sp., (primarily B. malikii), and Paenibacillus sp.
According to an FDA release, these microorganisms are generally non-pathogenic. However, they do pose a risk to anyone who recently underwent nasal or sinus surgery, according to the FDA, which says "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."
The affected batches were distributed between July 2017 and September of this year.
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Customers 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. The company can be contacted by phone at 844-715-0113 or by email at sinusrecall@intelligenceofnature.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program by filling out this form online. Customers can also download or request the form over the phone at 800-332-1088, and then send the completed form to the address on the form.
For more information on the affected products see the full FDA release here.
