Neilmed Pharmaceuticals Inc: Device Recall
Recall #Z-1105-2025 · 12/28/2024
Class II: Risk
Recall Details
- Recall Number
- Z-1105-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Neilmed Pharmaceuticals Inc
- Status
- Ongoing
- Date Initiated
- 12/28/2024
- Location
- Santa Rosa, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 89,312
Reason for Recall
Due to nasal spray stability failure for bioburden.
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.
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.
Other Recalls by Neilmed Pharmaceuticals Inc
- Class III: Low Risk 06/24/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.