NeiMed NasoGel nasal spray recalled due to stability failure
Neilmed Pharmaceuticals is recalling NasoGel for Dry Noses due to stability failure that may allow microbial growth. The product was distributed across 30 U.S. states and to five countries.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving potential microbial contamination in a product applied to nasal membranes. No illnesses or injuries are reported, placing it in the 'risk-of-harm products where injury has not yet been reported' category.
Plain-English summary
Neilmed Pharmaceuticals Inc is recalling NasoGel for Dry Noses, a saline-based gel spray designed to moisturize and lubricate nasal passages. The recall affects 89,312 units with UPC 00705928045309 across multiple SKU configurations and lot numbers.
The product is being recalled due to stability failure related to bioburden concerns. The spray's formulation has failed to maintain adequate stability and may allow microbial contamination to develop.
The affected product was distributed nationwide across 30 U.S. states including 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, as well as internationally to Bahrain, Ireland, Malaysia, Mexico, and the United Kingdom.
The recalled product
- 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…
- Manufacturer
- Neilmed Pharmaceuticals Inc
- Affected units
- 89,312
Distribution
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