Intersect ENT, Inc. recalls SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menl

Recalled January 25, 2023 · FDA recall D-0167-2023 · Intersect ENT

Hazard

Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months. · FDA Class III

Units

9898 pouches

Sold at

Nationwide

Description

Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.

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.

Manufacturer(s)

Intersect ENT, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →