Biomic Sciences is recalling all lots of its ION Sinus Support, ION Biome Sinus and Restore Sinus Spray products after the U.S. Food and Drug Administration testing found the product to contain microbial contamination.
The drops were found to have been contaminated with Microbacterium sp., Fictibacillus sp., Bacillus sp., (primarily B. malikii), and Paenibacillus sp.
According to the FDA, the population most at risk would be people who recently underwent nasal or sinus surgery.
The FDA warned that “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.
The product is used as a nasal rinse and is packaged in individual boxes of one or two nasal spray dispensers.
Here are the lots covered by this recall:
- ION Sinus Support, sold from September 2021 through September 20, 2023.
- ION Biome Sinus, sold from September 2019 through September 2021.
- Restore Sinus Spray, sold from June 2017 through September 2019.
The sinus spray was sold across the country at wholesale and retail outlets, as well as online. Consumers are urged to take a photo of the lot number and then discard the spray. Use the number when you contact Biomic Sciences to arrange a refund.
Parties with questions about this recall can contact ION Sinus Recall Team at 1-844-715-0113, Monday-Friday from 9 a.m. to 5 p.m. ET, or email@example.com.
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