A popular nasal spray sold across the United States is being recalled due to potential mold and bacterial contamination. The U.S. Food and Drug Administration (FDA) has urged consumers to immediately stop using the product, as it may pose a risk of life-threatening infections, particularly for individuals with weakened immune systems.
Key Takeaways
- ReBoost Nasal Spray is recalled nationwide due to yeast/mold and bacterial contamination.
- The contamination includes unsafe levels of the bacteria Achromobacter.
- There is a risk of life-threatening infections, especially for immunocompromised individuals.
- No adverse events have been reported to date.
- Consumers should discontinue use and return the product for a refund.
Product Details and Contamination Concerns
The voluntary recall affects one lot of ReBoost Nasal Spray, manufactured by MediNatura New Mexico Inc. Testing revealed the presence of yeast/mold and microbial contamination, specifically the bacteria Achromobacter, at levels exceeding specifications. The FDA stated there is a “reasonable probability” that adverse health consequences, including severe infections, could occur if the product is used by immunocompromised individuals.
Identifying the Recalled Product
The recalled nasal spray is packaged in a 20mL bottle, typically within a white and yellow carton. Consumers can identify the affected product by the following details:
- Product Name: ReBoost Nasal Spray
- Lot Number: 224268
- Expiration Date: December 2027
- NDC Number: 62795-4005-9
- UPC: 787647 10186 3
Consumer Actions and Recommendations
Consumers nationwide are strongly advised to immediately discontinue using the recalled ReBoost Nasal Spray. Those who purchased the product directly from MediNatura should contact the company for a refund. For purchases made through retailers, consumers should return the product to the place of purchase for a full refund. If any health problems arise that may be related to the use of this product, individuals should consult a healthcare provider. While no adverse events have been reported in connection with this recall, the company is conducting the recall out of an abundance of caution.
Sources
- Nasal spray recalled due to mold, bacterial contamination – NBC Chicago, NBC 5 Chicago.
- Nasal Spray Recalled Nationwide for ‘Life-Threatening Infections,’ Potential Mold, People.com.
- FDA Announces Nationwide Recall of Nasal Spray Due to Bacterial Contamination, Health: Trusted and Empathetic Health and Wellness Information.