Recall Z-1105-2025— Neilmed Pharmaceuticals Inc
Class II · Ongoing
Class II FDA medical device recall by Neilmed Pharmaceuticals Inc, initiated 2024-12-28. FDA's recall record names no specific 510(k) clearance for this event. 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: Due to nasal spray stability failure for bioburden..
- Recalling firm
- Neilmed Pharmaceuticals Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-12-28
- Firm location
- Santa Rosa, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.