Class III
Terminated
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.
- Company
- Intersect Ent, Inc.
- Recall Initiated
- January 4, 2023
- Posted
- January 25, 2023
- Recall Number
- D-0167-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 9898 pouches
- Firm Location
- Menlo Park, CA, United States
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.
Distribution
Nationwide
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.
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