MediNatura New Mexico is voluntarily recalling all lots of ReBoost Nasal Spray to the consumer level.
The product has been found to contain yeast, mould and microbial contamination at levels above specifications.
One species has been identified as Achromobacter, a bacterium that can cause infections in people with certain immunosuppressive conditions such as cystic fibrosis.
MediNatura New Mexico has also expanded its recall to include all lots of ClearLife Nasal Spray to the consumer level due to microbial contamination.
This expansion has been initiated due to the company's further investigative efforts.
Risk Statement: There is a reasonable probability that adverse health consequences, including life-threatening infections, will occur with use of the product in the immunocompromised population.
To date, MediNatura has not received any reports of adverse events related to this recall.
ReBoost Nasal Spray is used as a homoeopathic nasal spray to temporarily relieve nasal congestion, sinus headache and pressure, postnasal drip, sneezing, runny nose and nasal itching and is packaged in a 20 mL bottle, which is further packaged in a white and yellow carton.
The NDC number is 62795-4005-9 and the UPC# is 787647 10186 3.
The recalled ReBoost product includes all lots within expiration to ensure consumer safety [Product with Expiration date of 12/2022 to 12/2025].
ClearLife Allergy Nasal Spray is used as a homoeopathic nasal spray to temporarily relieve 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 product is packaged in a 20 mL bottle, which is further packaged in a white and green carton.
The NDC number is 62795-4006-9 and the UPC# is 787647 10188 7.
The recalled ClearLife product includes all lot numbers within expiration to ensure the safety of consumers [Product with Expiration date of 12/2022 to 12/2025].
The products can be identified by their bottle labels and cartons.
ReBoost and ClearLife were distributed nationwide via retail and internet sales (medinatura.com).
All customers should immediately discontinue using the products under recall.