The FDA has issued an immediate recall of all lots of ION* Sinus Support, ION* Biome Sinus, and Restore Sinus Spray due to the presence of potentially deadly bacteria. The manufacturer, Biomic Sciences, is working in cooperation with the FDA to recall lots distributed between June 2017 and September 2023. As of the writing of this notice, no adverse effects have yet been reported.
SUMMARY
Date of Recall:
Announced: September 29, 2023
Public Notification: October 2, 2023
Name(s) of Drug:
ION* Sinus Support Nasal Spray
ION* Biome Sinus Nasal Spray
Restore Sinus Spray
Company Name:
Biomic Sciences
Drug Indication:
Nasal Rinse
Post-Operative Nasal Rinse
Product Description
Each spray is individually bottled and packaged in a box labeled with brand information. The nasal spray dispensers are clearly marked with the brand or spray name. Wholesale and retail locations nationwide and online distributed the over-the-counter nasal sprays. The products were also sold directly to consumers at IntelligenceofNature.com.
Reason for Recall
During routine testing, the FDA noted that several pathogenic and nonpathogenic bacteria were present in the nasal spray. While some of the microorganisms identified are unlikely to become pathogenic, others are prone to causing deadly infections.
Impacts
Consumers, particularly those with a recent sinus or nasal surgery history, who continue to use the contaminated nasal spray are at risk of contracting deadly infections. The bacteria found within the spray can lead to serious complications within the nasal passage. These infections can spread quickly throughout the body, possibly leading to death.
Recall Lot Information
All lots of the sprays listed that were sold during the identified sales period are being recalled. Consumers who possess sprays that may have been distributed during the times listed should read further to determine what actions must be taken to participate in the recall.
Product Description |
Sales Period |
| ION* Sinus Support |
Sept 2021-Sept 20, 2023 |
| ION* Biome Sinus |
Sept 2019-Sept 2021 |
| Restore Sinus Spray |
June 2017-Sept 2019 |
Have you found that your medication is part of the recall? Here’s what you should do:
Consumers
- Call your doctor right away. Report the use of the recalled medication.
- Monitor your health for any adverse symptoms and notify your physician if any concerns are noted.
- Consumers with questions may contact the ION* Sinus Recall Team at 1-844-715-0113. They are available Mon-Fri from 9:00 a.m. to 5:00 p.m. (EST). You can also contact them via email at sinusrecall@intelligenceofnature.com.
- If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Retailer
- Examine all inventory and remove stock affected by the recall immediately.
- Contact the ION* Sinus Recall Team at 1-844-715-0113 or utilize sinusrecall@intelligenceofnature.com to contact them via email. Notify them of any recalled batches that have already been sold to consumers.
- Notify affected consumers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Wholesaler
- Examine all inventory and remove stock affected by the recall immediately.
- Contact the ION* Sinus Recall Team at 1-844-715-0113 or utilize sinusrecall@intelligenceofnature.com to contact them via email. Notify them of any recalled batches that have already been shipped to retailers.
- Notify affected retailers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
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Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or reach out to her directly on LinkedIn!