ION and Restore Sinus Spray Recall Issued Over Microbial Contamination Risks
Biomic Sciences has issued a recall for all lots of its ION and Restore sinus sprays, due to a risk that the products may cause severe and potentially life-threatening bacterial and fungal infections.
The U.S. Food and Drug Administration (FDA) announced the ION and Restore sinus spray recall on October 2, indicating that the agency has identified several strains of bacteria and fungi in the products, including Microbacterium sp., Fictibacillus sp., Bacillus sp., (primarily B. malikii), and Paenibacillus sp.
Federal regulators warn that exposure to the microorganisms can result in invasive bacterial or fungal infections in the sinuses or bloodstream, including rhinosinusitis, bacteremia, fungemia, or disseminated fungal infections, which can spread to other organs and areas of the body.
For individuals who recently underwent nasal or sinus surgery, officials warn that there may be a particularly high risk of sustaining severe and potentially life-threatening adverse health events from the microbial contamination.
ION Sinus Spray Recall Lawsuits
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ION and Restore Sinus Spray Recall
The recall includes all lots of ION Sinus Support Sprays distributed from September 2021 through September 2023, ION Biome Sinus Sprays distributed from September 2019 through September 2021, and Restore Sinus Sprays sold from June 2017 until September 2019.
The sprays were advertised to rinse, soothe, and protect the nasal and sinus passages using minerals extracted from soil, and were distributed online, as well as to wholesale and retail outlets.
To date, Biomic Sciences has not received any reports of injuries or illnesses in relation to the recall, and did not specify how the products became contaminated in the recall announcement.
Consumers are being asked to stop using the products and discard them immediately. They should take a photo of the lot number on the bottom of the bottle before discarding it, and complete the manufacturer’s online refund request form at https://intelligenceofnature.com/pages/ion-sinus-update to receive a refund.
Individuals who purchased the recalled products from Amazon within the past 60 days are being asked to request a refund directly from Amazon. However, they may request a refund from Biomic Sciences, if they purchased the spray more than 60 days ago, by completing the online refund request form and selecting Amazon as the original place of purchase.
For more information, the ION Sinus Recall Team can be contacted by phone at 1-844-715-0113 Monday through Friday from 9:00 am to 5:00 pm ET, or email email@example.com.
The FDA also urges consumers to report any adverse reactions they experienced after using the recalled sinus sprays to their healthcare provider, and to report any quality problems to the MedWatch Adverse Event Reporting program.
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