Intersect ENT, Inc.: Drug Recall
Recall #D-0167-2023 · 01/04/2023
Class III: Low Risk
Recall Details
- Recall Number
- D-0167-2023
- Classification
- Class III
- Product Type
- Drug
- Recalling Firm
- Intersect ENT, Inc.
- Status
- Terminated
- Date Initiated
- 01/04/2023
- Location
- Menlo Park, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9898 pouches
Reason for Recall
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
Product Description
SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menlo Park, CA 94025, NDC 10599-003-01.
Distribution Pattern
Nationwide
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.