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ALBUQUERQUE, N.M. - MediNatura is voluntarily recalling one lot of its ReBoost Nasal Spray, after it was found to contain mold and microbial contamination.
The recall was published on Wednesday by the U.S. Food and Drug Administration.
Reboost nasal spray recalled
What they're saying:
According to the company, the nasal spray had been found to contain yeast/mold and microbial contamination with one species identified as Achromobacter, at levels above specifications.
"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 company said in a statement.
To date, MediNatura has not received any reports of adverse events related to this recall.
Recalled Reboost nasal spray sold nationwide
Big picture view:
The product is used as a homeopathic nasal spray to temporarily relieve nasal congestion, sinus headache and pressure, postnasal drip, sneezing, runny nose and nasal itching.
Product photo of the ReBoost Nasal Spray (Credit: FDA)
ReBoost was distributed nationwide via retail and internet sales.
The recalled product is packaged in a 20mL 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 the following lot number 224268 with an expiration date of 12/2027.
Customers should discontinue using recalled nasal spray
What you can do:
The recall notice said that all customers should immediately discontinue using the ReBoost under recall.
FILE: Woman using nasal spray for relief from allergies or congestion. (Credit: Getty Images)
Customers who purchased the product directly from MediNatura New Mexico, Inc. should contact MediNatura New Mexico, Inc. at recall@medinatura.com to arrange for a refund.
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Consumers who purchased the product at retailers should return it to the place of purchase.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
The Source: The information for this story was provided by a recall notice distributed by the U.S. Food and Drug Administration (FDA). This story was reported from Los Angeles.