FDA-Drug2023-01-25Class III
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.
Intersect ENT, Inc.
Hazard
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
Sold states
Nationwide
Affected count
9898 pouches
Manufactured in
1555 Adams Dr, N/A, Menlo Park, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0167-2023Don't want to check this manually?
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