MediNatura New Mexico, Inc. has announced a voluntary nationwide recall of one lot of its ReBoost Nasal Spray due to the presence of yeast, mold, and microbial contamination, including the identification of Achromobacter at levels above specified limits.
The company stated, "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. To date, MediNatura has not received any reports of adverse events related to this recall."
ReBoost Nasal Spray is marketed as a homeopathic remedy for temporary relief from nasal congestion, sinus headache and pressure, postnasal drip, sneezing, runny nose, and nasal itching. The recalled product comes in a 20mL bottle packaged in a white and yellow carton with NDC number 62795-4005-9 and UPC number 787647 10186 3. The affected lot is numbered 224268 with an expiration date of December 2027.
Distribution was nationwide through both retail outlets and online sales via medinatura.com.
Customers are advised to stop using the recalled product immediately. Those who purchased directly from MediNatura should contact the company at recall@medinatura.com for a refund. Consumers who bought the product at retail stores are encouraged to return it to their place of purchase.
For questions about the recall, consumers can reach MediNatura New Mexico, Inc. by phone at 800-621-7644 or by email at recall@medinatura.com during business hours Monday through Friday. Individuals experiencing any issues related to this drug should consult their healthcare provider.
Adverse reactions or quality problems associated with this product can be reported to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm or by downloading forms from www.fda.gov/MedWatch/getforms.htm. Reports may also be submitted by mail or fax as instructed on these sites.
According to MediNatura New Mexico, Inc., "This recall is being conducted with the knowledge of the U.S. Food and Drug Administration."
