# FDA recall Z-1105-2025

> **Neilmed Pharmaceuticals Inc** · Class II · device recall initiated 2024-12-28.

## Product

NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT  NasoGel Spray is a saline-based gel formula that can be sprayed to moisturize and lubricate dry and irritated anterior or front of nasal passages caused by dry climate and indoor heat.

## Reason for recall

Due to nasal spray stability failure for bioburden.

## Distribution

Worldwide - U.S. Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OR, PA, RI, SC, TN, TX, VA, VT, WA, and WI. The countries of Bahrain, Ireland, Malaysia, Mexico, and United Kingdom.

## Key facts

- **Recall number:** Z-1105-2025
- **Recalling firm:** Neilmed Pharmaceuticals Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-28
- **Report date:** 2025-02-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Santa Rosa, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1105-2025

## Citation

> AI Analytics. FDA recall Z-1105-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1105-2025. Source: US FDA. Licensed CC0.

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