Home / Recalls / Intersect ENT, Inc. / D-0167-2023

D-0167-2023 Class III Terminated

Recalled by Intersect ENT, Inc. — Menlo Park, CA

Recall Details

Product Type: Drugs
Report Date: January 25, 2023
Initiation Date: January 4, 2023
Termination Date: August 21, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9898 pouches

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.

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 Pattern

Nationwide

Code Information

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.