SINUVA — Class III drug recall D-0167-2023
Terminated recall by Intersect ENT, Inc., reported 2023-01-25, distributed nationwide. Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) spe
| Recall number | D-0167-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Intersect ENT, Inc., Menlo Park, CA, United States |
| Recall initiated | 2023-01-04 |
| Classified | 2023-01-19 |
| Reported by FDA | 2023-01-25 |
| Terminated | 2024-08-21 |
| Distributed | Nationwide (US) |
| Quantity | 9,898 pouches |
| Reason classes | specification failure |
| NDC | 10599-0003, 10599-0003-01 |
| Lot numbers | 10111003, 10203002, 10302002, 10325001, 10519001, 10526002, 10602002, 10819004, 21092101, 21110402, 21111901 |
| Expiration dates | 2022-12-31, 2023-01-31, 2023-02-28, 2023-04-30, 2023-05-31, 2023-09-30, 2023-10-31, 2023-12-31 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0167-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.