FDAFDA · Food and drugs·Recall number D-0167-2023
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.
Published January 25, 2023 · Recall initiated: January 4, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SINUVA
- Manufacturer
- Intersect ENT, Inc.
- Distributor
- Nationwide
- Lot
- 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.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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