Why it was recalled
Microbial contamination of Non-Sterile Products
Product description
Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA
Lot numbers, UPCs & expiration codes
All lots within expiry.
Where it was sold
Nationwide in the United States and to Canada, New Zealand, Australia, Indonesia, Malaysia, Great Britain, and the Netherlands
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0069-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 29, 2023
- FDA report date
- Nov 1, 2023
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Biomic Sciences, LLC dba ION Intelligence of Nature
Original FDA data
Every field from FDA enforcement report D-0069-2024, exactly as published.
Show all FDA fields
- City
- Charlottesville
- State
- VA
- Status
- Terminated
- Country
- United States
- Event ID
- 93150
- Address
- 4351 Seminole Trl
- Code information
- All lots within expiry.
- Postal code
- 22911-8225
- Report date
- Nov 1, 2023
- Product type
- Drugs
- Recall number
- D-0069-2024
- Classification
- Class II
- Recalling firm
- Biomic Sciences, LLC dba ION Intelligence of Nature
- Termination date
- Jul 10, 2024
- Reason for recall
- Microbial contamination of Non-Sterile Products
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA
- Distribution pattern
- Nationwide in the United States and to Canada, New Zealand, Australia, Indonesia, Malaysia, Great Britain, and the Netherlands
- Recall initiation date
- Sep 29, 2023
- Initial firm notification
- Press Release
- Center classification date
- Oct 24, 2023