FDA issues product recall on sinus nasal sprays

Biomic Sciences, a well-known producer of sinus support products, has initiated a voluntary nationwide recall of several of its nasal spray products. The recall includes ION* Sinus Support, ION* Biome Sinus, and Restore Sinus Spray. This decision comes in response to findings by the U.S. Food and Drug Administration (FDA), which detected microbial contamination in these products.

Which products are affected?

The recall pertains to specific lots of the following Biomic Sciences products, which have been distributed from various sales periods:

• 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.

These products are primarily used as nasal rinses and are typically packaged in individual boxes containing one or two nasal spray dispensers. If you possess any of these products, it's essential to check the lot number on the bottom of the bottle to determine if your item is subject to the recall.

What are the health risks?

The recall has been initiated due to the presence of microbial contamination in the affected products. The specific microorganisms identified include Microbacterium sp., Fictibacillus sp., Bacillus sp. (primarily B. malikii), and Paenibacillus sp. While these microorganisms are generally non-pathogenic for most individuals, there is a substantial risk for a specific segment of the population.

Patients or individuals who have recently undergone nasal or sinus surgery are at a heightened risk. For this group, the use of the contaminated products could potentially lead to severe or life-threatening adverse events, including:

1. Bacteremia or fungemia: The presence of bacteria or fungi in the bloodstream, which can lead to serious infections.
2. Invasive bacterial or fungal rhinosinusitis: Infections that penetrate the nasal and sinus tissues, potentially causing significant health complications.
3. Disseminated fungal infection: The spread of fungal infections throughout the body, which can be particularly dangerous.

It's important to note that as of now, Biomic Sciences has not received any reports of adverse events related to the use of these products. However, the company has taken proactive measures to prevent any potential risks to consumers.

Here's what to do if you purchased the product

If you have purchased any of the recalled Biomic Sciences products, it is crucial to take the following steps:

1. Stop using the product: Immediately cease using the affected product to prevent any potential health risks.
2. Check the lot number: Examine the bottom of the product bottle to locate the lot number.
3. Document the lot number: Take a photo of the lot number on the bottle before discarding it. You will need this information for the next step.
4. Contact Biomic Sciences: Reach out to Biomic Sciences to arrange a refund or further guidance. You can contact the ION* Sinus Recall Team at 1-844-715-0113 Monday – Friday from 9:00 am to 5:00 pm Eastern time or email them at sinusrecall@intelligenceofnature.com.
5. Consult your healthcare provider: If you have experienced any problems or symptoms that may be related to using these products, it is advisable to consult with your physician or healthcare provider promptly.
6. If you have encountered adverse reactions, report them to FDA'sMedWatch Adverse Event Reporting program.

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Sources:

FDA website