Drug recall D-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.
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.
Lots and codes
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.
Recall details
- Recalling firm
- Intersect ENT, Inc., Menlo Park, CA
- Quantity
- 9898 pouches
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 4, 2023
- Terminated
- August 21, 2024
Related products
- Sinuva – drug information
- NDC 10599-003 Sinuva · Mometasone Furoate 1350 ug/1 · Intersect ENT, Inc.