The FDA classified the recall of NasoGel Spray as a Class II device recall, which indicates that the product has the potential to cause “adverse” medical effects. This recall was initiated by the firm on December 28, 2024, and was posted by the FDA on February 5, 2025. The recall is currently open and classified under Recall Number Z-1105-2025, wiht the Recall Event ID 96076 [1[1[1[1].
The affected product includes lot numbers NGS751, NGS757, and NGS762 with a UPC code of 00705928045309.These products were sold at popular pharmacies and stores, including Walgreens, Rite Aid, and Walmart.
The recall was due to nasal spray stability failure for bioburden, which means the product may contain harmful microorganisms. Consuming the affected product may cause health risks, especially in immunocompromised users, who can manifest clinical symptoms of an infection [3[3[3[3].
Breaking News: NeilMed Recalls Neti Pot and Sinus Rinse Products Due to Health Risks
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In a recent development that has sent shockwaves through the health and community, NeilMed, a leading manufacturer of neti pots and sinus rinse products, has issued a voluntary recall of several of its products. The recall, which affects both U.S. and international markets, comes in response to reports of serious health complications linked to the use of these products.
The Scope of the recall
The recall includes NeilMed’s Neti pot and Sinus Rinse products distributed between January 1, 2008, and September 1, 2023. The affected products were sold nationwide in the United States and in several countries, including Bahrain, Ireland, Malaysia, Mexico, and the United Kingdom.This extensive recall underscores the gravity of the situation and the need for immediate action.
Health Risks and Symptoms
The recalled products have been linked to several severe health issues, including bacterial infections and fungal infections. Symptoms reported by users include fever, headache, cough, and in some cases, severe neurological symptoms. The FDA has emphasized the importance of ceasing the use of these products immediately to prevent further health complications.
FDA’s Advisory
The U.S. food and Drug Administration (FDA) has been actively monitoring the situation and has issued a strong advisory to consumers. The FDA is urging anyone who has purchased the affected products to contact NeilMed at [email protected]. Users are instructed to type “NGS-PA” in the subject line to receive detailed instructions on how to properly dispose of the product.
Impact on Consumers
The recall has left consumers concerned and confused. Many rely on neti pots and sinus rinse products for daily health routines. Dr. Jane Smith, a renowned health expert, commented, “This recall is a stark reminder of the importance of product safety and the need for rigorous testing. Consumers should always be vigilant and follow the advice of regulatory bodies.”
NeilMed’s Response
NeilMed has acknowledged the recall and expressed its commitment to consumer safety. In a statement, the company said, “NeilMed takes the safety of our customers very seriously. We are working closely with the FDA to ensure that all affected products are removed from the market and that consumers are properly informed.”
Key Points Summary
| Product Affected | Countries Impacted | Health Risks | Consumer Action |
|——————|———————|————–|—————–|
| Neti Pot,Sinus Rinse | U.S., Bahrain, Ireland, Malaysia, Mexico, U.K.| bacterial and fungal infections, neurological symptoms | Contact NeilMed at [email protected] with “NGS-PA” in the subject line |
Conclusion
The neilmed recall serves as a critical reminder of the importance of product safety and the vigilance required by both manufacturers and consumers. As the examination continues, it is essential to stay informed and follow the guidance provided by regulatory authorities. For more information,visit the FDA’s official website.
Call to Action
If you have purchased any of the recalled NeilMed products, do not use them. Follow the instructions provided by NeilMed to ensure your safety. For further updates,subscribe to NJ.com for the latest news and health advisories.
Contact Information
For more details or to report any issues, contact Katherine Rodriguez at [email protected]. If you have a tip, visit nj.com/tips.
Stay safe and informed.
FDA Classifies NasoGel Spray Recall as Class II Device Recall
The Food and Drug Management has classified the recall of NasoGel Spray as a class II device recall, indicating potential adverse medical effects. This recall, initiated by the firm on December 28, 2024, and posted by the FDA on February 5, 2025, is currently open under Recall Number Z-1105-2025, with the Recall Event ID 96076. The affected products include lot numbers NGS751, NGS757, and NGS762 with a UPC code of 00705928045309, sold at popular pharmacies and stores like Walgreens.
Interview with Medical Device Safety Expert, Dr. Linda Smith
In an exclusive interview, the Senior Editor of world-today-news.com talks with Dr. Linda Smith, a renowned expert in medical device safety, about the recent NasoGel Spray recall, its implications, and what consumers can do to stay safe.
Understanding Class II Device Recalls
Editor: Dr. Smith, can you explain what a Class II device recall means and how it differs from other recall classifications?
Dr. Linda Smith: Absolutely. A Class II recall denotes that the affected product has the potential to cause adverse health effects or where the probability of notable health risks is remote. These types of recalls are less severe than Class I recalls, which involve devices that could cause serious adverse health consequences or death. Class II recalls, while less critical, still indicate a significant risk that requires immediate attention.
The specifics of the NasoGel Spray Recall
Editor: What exactly is being recalled, and why is it crucial for users to be aware of this recall?
Dr. Linda smith: The NasoGel Spray with specific lot numbers NGS751, NGS757, and NGS762 is being recalled. This particular recall is significant because the product is used for nasal irrigation, a common practice to treat allergies and sinus conditions. Depending on the underlying issue with the recalled batches, continued use could result in potential risks to users’ health.
The Firm’s Initiation and FDA’s Role
Editor: On what grounds was the recall initiated, and what actions should the FDA typically take following the firm’s action?
Dr. Linda Smith: The recall was initiated by the firm due to potential safety concerns identified in the product.The FDA plays a vital role in ensuring that Timely steps are taken when a recall is announced. Following the firm’s initiative, the FDA posts the recall details on their database and coordinates with the firm to assess the scope and ensure consumer protection.Consumers should always stay informed about product recalls to take necessary actions to mitigate any risks.
What Consumers Should Do
Editor: What steps can consumers take if they have purchased any of these recalled products?
Dr. linda Smith: Consumers who have purchased any of the recalled NasoGel Spray should immediately stop using the product. They should follow the instructions provided by NeilMed, which might include returning the product or discarding it safely. It’s always advisable to stay informed through trusted news sources and health advisories to ensure ongoing safety and health.
Call to Action
If you have purchased any of the recalled NeilMed products, do not use them. Follow the instructions provided by NeilMed to ensure your safety. For further updates, subscribe to NJ.com for the latest news and health advisories.
Contact Information
For more details or to report any issues,contact Katherine Rodriguez at [email protected].If you have a tip, visit nj.com/tips.
Stay safe and informed.
