FDA Recall: Sinus Spray Products 　

Emergency Message System

October 3rd, 2023

Biomic Sciences is voluntarily recalling all lots of ION* Sinus Support, ION* Biome Sinus, and Restore Sinus Spray products to the consumer level.

Summary

Company Announcement Date: September 29, 2023
FDA Publish Date: October 02, 2023
Product Type: Drugs
Reason for Announcement: Potential Contamination with Microbacterium spp., Fictibacillus spp., Bacillus spp., and Paenibacillus spp.
Company Name: Biomic Sciences
Brand Name: Ion and Restore brands
Product Description: Nasal Sprays

Company Announcement

FOR IMMEDIATE RELEASE – September 29, 2023 – Charlottesville, VA - 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).

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. To date, Biomic Sciences has not received any reports of adverse events related to this product.

The product is used as a nasal rinse and is packaged in individual boxes of one or two nasal spray dispensers (see the product pictures below). All lots of the following products are covered by this recall:

The affected lots were distributed to wholesale and retail outlets, as well as sold directly to consumers online.

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 (contact information provided below).

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.