# FDA recall D-0010-2023

> **Ingenus Pharmaceuticals Llc** · Class II · drug recall initiated 2022-09-30.

## Product

Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408;  NDC 50742-317-25 UPC 3 50742 31725 7

## Reason for recall

Out of specification for related substances (impurities).

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0010-2023
- **Recalling firm:** Ingenus Pharmaceuticals Llc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2022-09-30
- **Report date:** 2022-10-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Orlando, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0010-2023

## Citation

> AI Analytics. FDA recall D-0010-2023. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0010-2023. Source: US FDA. Licensed CC0.

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