Reported Jan 25, 2023 · Terminated
SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive,…
Intersect ENT, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intersect ENT, Inc. · 1555 Adams Dr · Menlo Park, CA · 94025-1439
Is this the product you have?
- 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.
- Lot codes and dates
Lot #s: 10111003Exp 12/31/202210203002Exp 01/31/20231030200210325001Exp 02/28/20231051900110526002Exp 04/30/202310602002Exp 05/31/202310819004Exp 09/30/20232109210121111901Exp 10/31/202321110402Exp 12/31/2023
- Amount recalled
- 9898 pouches
Where it was sold
- 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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