Biomic Sciences Issues Voluntary Nationwide Recall of ION* Sinus Support, ION* Sinus, and Restore Sinus Spray Products Due to Microbial Contamination
September 29, 2023 – Charlottesville, VA - Biomic Sciences is voluntarily recalling all lots of ION* Sinus Support, ION* 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).
We appreciate your patience as our ION* Sinus Support Recall Team continues to respond to emails and refund requests.
Although we have been able to process many refund requests, we are aware many of our customers are still waiting for a response or refund.
If you have completed the ION* Sinus Support Refund Form, and have not received your refund:
The ION* Sinus Support Recall Team has selected the third-party payment provider, Tipalti, to process your refund. Keeping your information safe and secure is our highest priority as well as processing your refund in a timely manner. Tipalti is committed to doing just that.
Please keep an eye on your email for correspondence from Tipalti. They will be contacting you on our behalf to confirm your name, mailing address, and preferred form of payment for your refund. The email from Tipalti will be sent to the email address provided on your refund form.
Please do not send multiple emails to the ION* Sinus Support Recall Team. Multiple emails, phone calls and different email addresses for the same customer have significantly delayed our ability to respond to customers in a timely manner.
Thank you for your continued patience.
The ION* Sinus Support Recall Team
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:
September 2021 — September 20, 2023
September 2019 — September 2021
June 2017 — September 2019
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 by filling out the form below.
Parties with questions about this recall can contact ION* Sinus Recall Team at 1-844-715-0113 Monday – Friday from 9:00 am to 5:00 pm Eastern time or firstname.lastname@example.org. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Amazon Refunds: If you purchased ION* Sinus Support, ION* Sinus or Restore Sinus Spray from Amazon, please fill out the Sinus Recall Refund Request Form and be sure to include your Amazon Order Number.