Intersect ENT, Inc. recalls SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Men…
- Recall date
- January 4, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0167-2023
- FDA classification
- Class III
- Brand / firm
- Intersect ENT, Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
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