Intersect ENT recalls

FDA enforcement reports naming Intersect ENT, Inc. as the recalling firm.

Recall reports: 1
Class I (serious): 0
Most recent report: Jan 25, 2023

Severity

Jan 25, 2023SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, inte…Drug · Intersect ENT, Inc.Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.Class III