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.
Reported: January 25, 2023 Initiated: January 4, 2023 #D-0167-2023
Product Description
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.
Details
- Recalling Firm
- Intersect ENT, Inc.
- Units Affected
- 9898 pouches
- Distribution
- Nationwide
- Location
- Menlo Park, CA
Frequently Asked Questions
What product 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.. Recalled by Intersect ENT, Inc.. Units affected: 9898 pouches.
Why was this product recalled? ▼
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 25, 2023. Severity: Low. Recall number: D-0167-2023.
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