FDA Issues Wide-Ranging Recall of Nasal Spray

A substantial recall of nasal spray has been initiated by the U.S. Food and Drug Administration due to microbial failure. Last week, the FDA disclosed details about the recall impacting NeilMed Pharmaceuticals’ NasoGel Spray. Below, you will find a compilation of the lots that are affected by this recall. Additionally, there is another pertinent recall to take note of at present, concerning a nasal spray product. NeilMed Pharmaceuticals Inc., the maker of NasoGel Spray, has issued a global recall encompassing 89,312 units of its sprays due to identified concerns related to a “microbial failure”. The FDA announced the recall last week. As per the FDA’s advisory, NeilMed received 11 reports from consumers pertaining to an “unpleasant odor” emanating from the product. Subsequently, a blend of regular testing protocols and consumer grievances has spurred the company to take corrective action by recalling three specific lots of the spray. In an initial communication to customers on December 28, 2024, NeilMed notified them that the product was being recalled owing to the presence of “microbial failure detected during routine stability testing”. The term “microbial failure” encompasses various scenarios, including the existence of bacteria or a deficiency in sterility. This recall has been categorized by the FDA as a Class 2 Device Recall, indicating products with the potential to cause “adverse” medical consequences. This classification stands as the second-highest rating granted to an FDA product recall. If you suspect you possess an affected product, please refrain from using it and reach out to NeilMed to receive guidance on proper disposal. The recall pertains to NeiMed NasoGel for Dry Noses, covering lots NGS751, NGS757, and NGS762, with the UPC code: 00705928045309. The FDA has specified that several SKUs listed below were included in the recall: 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 The impacted product was distributed in 20 states and retailed in the nations of Ireland, Mexico, and the United Kingdom. This particular product was accessible for purchase both in physical stores and online via platforms like Amazon. For a comprehensive list of the SKUs, product codes, and states influenced by this recall, please visit the FDA’s official website. NeilMed’s website has also posted a statement concerning the recall, providing additional insights into potential outcomes for customers who used the product and advising on whom to contact with queries. The statement reads, “NeilMed is undertaking a voluntary recall of NasoGel Spray lots NGS751, NGS757, and NGS762 distributed in 2024 due

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