Drug product
Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA
D-0069-2024
Product summary
- Event
- Event 93150
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0069-2024
Official wording
Reason: Microbial contamination of Non-Sterile Products
Code information: All lots within expiry.
Distribution pattern: Nationwide in the United States and to Canada, New Zealand, Australia, Indonesia, Malaysia, Great Britain, and the Netherlands
Derived failure modes
-
Microbial contamination
Microbial contamination