Recalls / Class III
Class IIID-0167-2023
Product
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.
- Brand name
- Sinuva
- Generic name
- Mometasone Furoate
- Active ingredient
- Mometasone Furoate
- Route
- Intrasinal
- NDC
- 10599-003
- FDA application
- NDA209310
- Affected lot / code info
- Lot #s: 10111003, Exp 12/31/2022; 10203002, Exp 01/31/2023; 10302002, 10325001, Exp 02/28/2023; 10519001, 10526002, Exp 04/30/2023; 10602002, Exp 05/31/2023; 10819004, Exp 09/30/2023; 21092101, 21111901, Exp 10/31/2023; 21110402, Exp 12/31/2023.
Why it was recalled
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
Recalling firm
- Firm
- Intersect ENT, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1555 Adams Dr, N/A, Menlo Park, California 94025-1439
Distribution
- Quantity
- 9898 pouches
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2023-01-04
- FDA classified
- 2023-01-19
- Posted by FDA
- 2023-01-25
- Terminated
- 2024-08-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0167-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.