Safety Report: Ion & Restore brands Nasal Sprays - recalled due to due to Microbial Contamination, USA

United States

Biomic Sciences is voluntarily recalling all lots of ION* Sinus Support, ION* Biome Sinus, and Restore Sinus Spray products to the consumer level. FDA testing found the product to contain microbial contamination identified as Microbacterium sp., Fictibacillus sp., Bacillus sp., (primarily B. malikii), and Paenibacillus sp (these microorganisms are generally non-pathogenic). These products were distributed to wholesale and retail outlets, as well as sold directly to consumers online. To date, Biomic Sciences has not received any reports of adverse events related to this product.

Risk Statement: In the population most at risk, patients or individuals who recently underwent nasal or sinus surgery, 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.

The product is used as a nasal rinse and is packaged in individual boxes of one or two nasal spray dispensers. The recalled products are:
- ION* Sinus Support. Sales Period: September 2021 through September 20, 2023
- ION* Biome Sinus. Sales Period: September 2019 through September 2021
- Restore Sinus Spray. Sales Period: June 2017 through September 2019

Biomic Sciences is notifying its distributors and customers by electronic communications and is arranging for the disposition of all recalled products. Consumers and other parties that have the recalled product should stop using the product and either discard it or take a photo of the lot number on the bottom of the bottle before discarding it and provide that to Biomic Sciences to arrange a refund.

In case you experience harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Biomic Sciences
Brand name: Ion and Restore brands
Product recalled: Nasal Sprays
Reason of the recall: Potential Contamination with Microbacterium spp., Fictibacillus spp., Bacillus spp., and Paenibacillus spp.
FDA Recall date: October 02, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/biomic-sciences-issues-voluntary-nationwide-recall-ion-sinus-support-ion-biome-sinus-and-restore