Neilmed Pharmaceuticals Inc recalls NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL…

Recall date

December 28, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1105-2025

FDA classification

Class II

Brand / firm

Neilmed Pharmaceuticals Inc

Sold / distributed

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.

Why it was recalled

Due to nasal spray stability failure for bioburden.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.