FDAJanuary 4, 2023drug
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 recall recorded by the U.S. Food & Drug Administration.
The hazard
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
What to do
FDA enforcement status: Terminated
Brands named
intersect entintersect
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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