MOMETASONE FUROATE Recall D-0167-2023
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.
MOMETASONE FUROATE Recall D-0167-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0167-2023 |
| Event ID | 91348 |
| Brand | SINUVA |
| Generic Name | MOMETASONE FUROATE |
| Manufacturer | MOMETASONE FUROATE |
| Original Package? | 1 |
| Active Substance | MOMETASONE FUROATE |
| Drug Route | INTRASINAL |
| Distribution | Nationwide |
| Quantity | 9898 pouches |
| Recall Reason | Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months. |
| Drug Classification | Class III |
| Drug Code Info | 20230125 |
| Product NDC | 10599-003 |
| Recall Initiation Date | 20230104 |
| Report Date | 20230125 |
| Classification Date | 20230119 |
| Address | 1555 Adams Dr Menlo Park, CA 94025-1439 United States |
| Recalling Firm | Intersect ENT, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 04201GDN4R |
| Drug Application Number | NDA209310 |
| Structured Product Labeling (SPL ID) | 23a7565b-80c9-4361-afcc-52324d1fe671 |
| Structured Product Labeling (SPL Set ID) | e33c1b23-cdc6-4f64-94ba-24b0b42c09bf |
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