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Recall notice

ReBoost Nasal spray recalled due to Product Contain Yeast/mold and Microbial Contamination, USA

1 month ago source fda.gov

United States

MediNatura New Mexico, Inc. is voluntarily recalling one lot of ReBoost Nasal Spray to the consumer level. The product has been found to contain yeast/mold and microbial contamination, with one species identified as Achromobacter, at levels above specifications. ReBoost was distributed nationwide in the United States via retail and internet sales on the Medinatura website.

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.

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 and 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. The product can be identified by its bottle label and carton.

All customers should immediately discontinue using the ReBoost under recall. Customers who purchased the product directly from MediNatura New Mexico, Inc. should contact MediNatura New Mexico, Inc. at their email to arrange for a refund. Consumers who purchased the product at retailers should return it to the place of purchase.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medinatura-new-mexico-inc-issues-voluntary-nationwide-recall-reboost-nasal-spray-due-microbial

#drugs #unitedstates

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