A widely distributed homeopathic nasal spray has been pulled from the market in a nationwide recall after testing revealed dangerous contamination, prompting urgent warnings from federal and state health authorities.
The U.S. Food and Drug Administration (FDA) announced that MediNatura New Mexico Inc. is recalling its ReBoost Nasal Spray due to microbial contamination. The agency stated the product “has been found to contain yeast/mold and microbial contamination with one species identified as Achromobacter bacteria at levels above specifications.”
This is not a routine precaution. The FDA has classified this as a serious health risk, noting there is a “reasonable probability that adverse health consequences, including life-threatening infections, will occur with use of the product in the immunocompromised population.”
What Product Is Affected?
The recall is specific to one lot of the over-the-counter homeopathic spray:
- Product: ReBoost Nasal Spray (20mL bottle in a white and yellow carton)
- Use: Marketed to reduce nasal congestion
- Lot Number: 224268
- Expiration Date: December 2027
- NDC #: 62795-4005-9
- UPC #: 787647 10186 3
The product was sold nationwide in stores and through online retailers.
What Are the Risks?
Using the contaminated spray could lead to serious infections, particularly for individuals with weakened immune systems, chronic respiratory conditions, or those recovering from surgery. The Hawaii State Department of Health, which also issued the alert, listed potential symptoms to watch for:
- Fever
- Swollen sinuses
- Severe headaches
- Facial pain or pressure
- Facial numbness
What Should You Do Immediately?
- STOP USING THE SPRAY. If you have the recalled lot (224268), discontinue use immediately.
- DO NOT RETURN IT TO A PHARMACY YET. The FDA provides separate instructions based on where you bought it:
- If purchased directly from MediNatura, contact the company at recall@medinatura.com to arrange a refund.
- If purchased from a retailer or online store, return it to the point of purchase for a refund.
- CONSULT A HEALTHCARE PROVIDER. If you have used this product and are experiencing any of the symptoms listed above, contact your doctor or healthcare provider promptly.
A Reminder on Homeopathic Product Regulation
This incident highlights an important consumer note: homeopathic products are not evaluated by the FDA for safety or efficacy. They can come to market without undergoing the rigorous approval process required for prescription or conventional over-the-counter drugs. This recall underscores the critical importance of buying from reputable manufacturers and being aware of recall notices, even for “all-natural” remedies.
As of the latest update, MediNatura reports no adverse events have been received related to this contamination. However, due to the severe potential risk, consumers are urged to act quickly to check their medicine cabinets and follow the recall instructions to ensure their safety.
referrence : https://people.com/nasal-spray-recalled-nationwide-for-life-threatening-infections-potential-mold-11868624