FDA recall Z-1105-2025

Neilmed Pharmaceuticals Inc · Class II · device

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

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

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