Z-1105-2025 Class II Ongoing
FDA device recall Z-1105-2025 was initiated by Neilmed Pharmaceuticals Inc on December 28, 2024 and is designated Class II. Reason for recall: Due to nasal spray stability failure for bioburden. The recall status is ongoing. Affected quantity: 89,312.
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2025
- Initiation Date
- December 28, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89,312
Product Description
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 Pattern
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.
Code Information
NasoGel Spray UDI-DI/UPC code: 00705928045309 SKU / Lot Numbers: GSP30-2R-48-ENU-USL / NGS751 GSP30-0R-96-ENU-USL / NGS757 and NGS762 GSP30-ARA-INTL / NGS762 GSP30-SWE-INTL / NGS754 GSP30-ENG-INT / NGS755 GSP30-MAL-INTL / NGS756 GSP30-SPA-INT / NGS760 and NGS761