# FDA recall D-0167-2023

> **Intersect ENT, Inc.** · Class III · drug recall initiated 2023-01-04.

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0167-2023
- **Recalling firm:** Intersect ENT, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-01-04
- **Report date:** 2023-01-25
- **Termination date:** 2024-08-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Menlo Park, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0167-2023

## Citation

> AI Analytics. FDA recall D-0167-2023. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/D-0167-2023. Source: US FDA. Licensed CC0.

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