In a swift move, the U.S. Food and Drug Administration announced on Tuesday that MediNatura New Mexico, Inc. is recalling all lots of its ReBoost Nasal Spray and ClearLife Nasal Spray. The recall follows a previous, limited recall of one lot of ReBoost after the product was found to contain yeast/mold and microbial contamination, with levels of Achromobacter above specifications. The new notice expands the scope of the recall to every batch of both homeopathic sprays sold online and in retail stores.
FDA Recall Details
The FDA notice cites microbial contamination that may be linked to Achromobacter as the trigger for the expanded recall of ReBoost. The same concern prompted the recall of ClearLife, where further investigative efforts detected contamination that may be linked to the same organism. The notice states:
“There is a reasonable probability that adverse health consequences including life-threatening infections will occur with use of the product in the immuno-compromised population,” the recall notice reads, adding that there have not been “any reports of adverse events” thus far.
Product Information and Intended Uses
Both sprays are sold in 20 mL bottles but are packaged differently: ReBoost comes in a white and yellow box while ClearLife’s packaging is white and green.
Advertised uses for the ReBoost spray include “temporarily relieve nasal congestion, sinus headache and pressure, postnasal drip, sneezing, runny nose, and nasal itching.”
The ClearLife Allergy spray can be used for “minor allergy symptoms such as sinus pressure, runny or itchy nose, nasal congestion, allergic rhinitis, sneezing, itchy or watery eyes, allergy-related headache, and itchy throat and skin.”
The recalled products carry the following identifiers and expiration dates:
| Product | NDC | UPC | Expiration |
|---|---|---|---|
| ReBoost Nasal Spray | 62795-4005-9 | 787647 10186 3 | 12/2022 to 12/2025 |
| ClearLife Allergy Nasal Spray | 62795-4006-9 | 787647 10188 7 | 12/2022 to 12/2025 |
How to Respond If You Own a Recalled Bottle
If you have a bottle of ReBoost Nasal Spray, the FDA advises you to stop using it immediately. You can either return the product to the store where it was purchased or contact MediNatura for a refund if it was bought online. MediNatura can be reached by email at [email protected].
If you have experienced any problems you believe are connected with the use of the nasal product, you should contact your healthcare provider.
Contact Information for Refunds and Questions
- Email: [email protected]
- Phone: 800-621-7644 (Monday-Friday, 8 a.m. to 5 p.m. MST)
MediNatura has not yet received any reports of illness linked to the recalled nasal sprays.
Key Takeaways
- All lots of ReBoost and ClearLife nasal sprays are recalled due to microbial contamination linked to Achromobacter.
- No adverse events have been reported to date, but the FDA warns of potential life-threatening infections in immunocompromised users.
- Consumers should stop using the products and seek refunds through the company’s contact channels.
The recall underscores the importance of vigilance in the distribution of over-the-counter homeopathic remedies and the role of the FDA in safeguarding public health.
