Sinus Recall FAQs
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Frequently asked questions
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What products are affected by this recall?
ION* Sinus Support (as well as previous iterations marketed as Restore Sinus Spray and ION* Sinus) are the only products being recalled. ION* Gut Support, ION* Gut Support For Pets, and ION* Skin Support are not affected by this recall.
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Who do I contact for a refund and any additional questions?
Parties with questions about this recall can contact ION* Sinus Recall Team at 1-844-715-0113 Monday – Friday from 9:00 am to 5:00 pm Eastern time or sinusrecall@intelligenceofnature.com. Please fill out the form here to initiate a refund (please do not fill out multiple return forms, as this will delay processing).
Our recall team is working as quickly and efficiently as possible to respond to all inquiries.
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Do I need to return my bottle?
No, we will not be requesting returns. Please dispose of your bottle as you see fit. If you would like a refund, please take a photo and make note of the batch number on the bottom and fill out the refund form found here.
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How do I dispose of Sinus Support?
There is no specific method of disposal needed. Please dispose of Sinus Support any way you see fit. If you would like a refund, please make sure to take a photo of the bottom of the bottle before disposal.
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Is ION* Gut Support impacted by this recall?
No, ION* Gut Support is not impacted by this recall. We continue to adhere to rigorous quality controls to ensure quality standards are met with this product.
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What does ‘non-pathogenic’ mean?
Nonpathogenic organisms are those that do not cause disease, harm or death to another organism. This, however, is not to say that these microbes cannot potentially cause harm, and we recommend disposing of your ION* Sinus Support.
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An explanation of Microbacterium sp., Fictibacillus sp (firmicutes)., Bacillus sp., (primarily B. malikii), and Paenibacillus sp.
- Microbacterium are a type of bacteria which are found in various environmental sources, such as soil and water. Microbacterium rarely cause human infection, but when they do, this is most commonly limited to patients who are immunocompromised.
- Fictibacillus are another type of bacteria that are found in environmental sources such as freshwater, hot springs, rivers, marine sediments, soil, industrial waste and metal ores. It is doubtful this bacterium causes infections in humans, as there are no significant published studies indicating illness caused by Fictibacillus.
- Bacillus malikii is a bacterium that has been recovered from a wide range of environments, including lakes, coastal marine regions, tannery wastewater and soil. It is doubtful this bacterium causes infections in humans, as there are no significant published studies indicating illness caused by Bacillus malikii.
- Paenibacillus is another bacterium that has been isolated from a variety of environments, including soil, plant roots, water sources, vegetable matter and insect larvae. Human infections caused by this bacterium are opportunistic in nature and tend to cause illness in immunocompromised patients or elderly individuals whose immune systems are generally weak. Paenibacillus infections have been primarily associated with medical device and indwelling catheter contamination, and with chronic hemodialysis patients.
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What are some examples of foods or environments that contain the above microbes?
Generally, any food that is grown in soil could contain any or all of them.
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Do these bacteria grow in the body?
Generally, certain types of bacteria may cause an infection if introduced into the body, but only under certain conditions, which may be related to the type of bacteria introduced, whether the bacterium is a potential pathogen and/or whether the individual is at an increased risk for infection. As stated in the recall announcement, these microbes are generally non-pathogenic and the population most at risk are patients or individuals who recently underwent nasal or sinus surgery.
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Can I expect adverse effects?
We cannot speculate, as we are not in a position to give medical advice. Prior to the date of recall, Biomic Sciences has not received any reports of adverse events related to this product. From what we understand, the risk of an adverse event is low. As stated in the recall announcement, the population most at risk are patients or individuals who recently underwent nasal or sinus surgery. However, we advise you to consult with a physician if you feel you’re experiencing any adverse events.
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Can you give an explanation of bacteremia or fungemia, invasive bacterial or fungal rhinosinusitis, and disseminated fungal infection?
Bacteremia is the presence of viable or living bacteria in the bloodstream. Bacteria can enter the bloodstream during surgery, after the placement of catheters or as a severe complication of infections. However, asymptomatic or transient bacteremia can occur in normal daily activities such as conducting oral hygiene and after minor medical procedures. In a healthy person, these clinically benign infections are transient and cause no further clinical or adverse events.
Fungemia is the presence of viable or living fungi or yeast in the bloodstream. It is most commonly observed in immunosuppressed or immunocompromised patients.
Invasive bacterial or fungal rhinosinusitis is defined as the invasion of bacteria or fungi into the nasal mucosa, the sinus mucosa, or deeper tissues.
Disseminated fungal infection is the presence of a fungal pathogen in the blood (fungemia) and/or any other deep-seated structure or organ. Disseminated fungal infections are more commonly observed in immunocompromised patients.
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When will Sinus Support be back in stock?
We do not currently have plans for restocking ION* Sinus Support. We are evaluating the future of the Sinus Support product line and how we can reintroduce it to the market in full compliance with FDA regulations for this new category.
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Can I continue taking Sinus Support if I want?
We appreciate your love of ION* Sinus Support. However, we can no longer recommend using Sinus Support and would encourage you to dispose of any remaining Sinus products in your possession immediately.
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