FDA 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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2023-01-04

Report date

2023-01-25

Termination date

2024-08-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Menlo Park, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0167-2023