CLASS II Drug recall · Reported 1 Nov 2023 · FDA Enforcement Report
Restore Sinus Spray recalled by Biomic Sciences
Biomic Sciences is recalling Restore Sinus Spray, distributed nationwide in the US. The recall was initiated on 29 Sep 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0069-2024
- FDA event ID
- 93150
- Recalling firm
- Biomic Sciences, Charlottesville, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Sep 2023
- FDA classified
- 24 Oct 2023
- Reported
- 1 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
Timeline
| 29 Sep 2023 | Recall initiated by company | |
| 24 Oct 2023 | Classified by FDA | +25 days |
| 1 Nov 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial contamination of Non-Sterile Products
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA
Where it was distributed
Nationwide in the United States and to Canada, New Zealand, Australia, Indonesia, Malaysia, Great Britain, and the Netherlands
Questions about this recall
Why was it recalled?
Microbial contamination of Non-Sterile Products
Which lots are affected?
All lots within expiry.
Where was it sold?
Nationwide in the United States and to Canada, New Zealand, Australia, Indonesia, Malaysia, Great Britain, and the Netherlands
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 93150This product is part of a recall event; the main page for the event is ION*Sinus Spray recalled by Biomic Sciences.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | ION*Sinus Spray recalled by Biomic Sciences | Biomic Sciences | Sterility | Nationwide | |
| CLASS II | ION* Sinus Support Nasal Spray recalled by Biomic Sciences | Biomic Sciences | Sterility | Nationwide |
More recalls from Biomic Sciences
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | ION* Sinus Support Nasal Spray recalled by Biomic Sciences | Biomic Sciences | Sterility | Nationwide |
| Drug | CLASS I | ION*Sinus Spray recalled by Biomic Sciences | Biomic Sciences | Sterility | Nationwide |