Biomic Sciences, headquartered in Charlottesville, Virginia, has voluntarily recalled all lots of its ION* Sinus Support, ION* Sinus, and Restore Sinus Spray because FDA testing revealed the products to be contaminated with microbes, according to the agency.
The microorganisms, all generally non-pathogenic, have been identified as “Microbacterium sp., Fictibacillus sp., Bacillus sp., (primarily B. malikii), and Paenibacillus sp.”
Officials say the recalled products pose the most risk to patients or individuals who have recently undergone nasal or sinus surgery, as there is a “reasonable probability” that use of the now-recalled products could lead to major, life-threatening health outcomes including “bacteremia or fungemia, invasive bacterial or fungal rhinosinusitis, or disseminated fungal infection.”
Indicated as nasal rinses, the products come individually-packaged in boxes containing either one or two nasal spray dispensers, as can be seen in photos attached to the FDA communication.
Initiated by Biomic Sciences on September 29, 2023, the recall covers all lots of the following three products (as listed above), each sold and distributed during specific sales periods to wholesale and retail outlets, as well as directly to consumers via online platforms:
- ION* Sinus Support
- Sales Period: September 2021 through September 20, 2023
- ION* Sinus
- Sales Period: September 2019 through September 2021
- Restore Sinus Spray
- June 2017 through September 2019
Since the announcement, the company has alerted its distributors and customers via electronic communications and has worked to arrange for the safe disposal of the recalled products. Biomic Sciences asks that consumers and associated parties discard any affected product. Before disposing of the product, consumers also have the option of submitting a photo of the lot number printed at the bottom of the product to receive a refund.
For further inquiries, Biomic Sciences’s ION* Sinus Recall Team can be reached at 1-844-715-0113 or via email at email@example.com, Monday through Friday, from 9:00 a.m. to 5:00 p.m. Eastern Time. Anyone experiencing health problems that may be linked to the product should consult their healthcare provider.
As the FDA continues to monitor this recall, the agency urges consumers to report any related adverse reactions or issues to its MedWatch program.
If you or a loved one has fallen ill as a consequence of using a contaminated medical drug, your family deserves compassionate legal support and fair compensation. Our seasoned attorneys at TruLaw work tirelessly to help people like you fight for the best outcome and hold responsible parties accountable for pain and suffering. To learn more about how we can get started, connect with us online or take our free Instant Case Evaluation ℠.