ReBoost, ClearLife Nasal spray 0.68 fl oz recalled due Microbial Contamination, USA

United States

MediNatura New Mexico, Inc. is voluntarily recalling all lots 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. It is also recalling all lots of ClearLife Nasal Spray to the consumer level. The product has been found to contain microbial contamination that may be linked to Achromobacter at levels above specifications. This expansion has been initiated due to the company's further investigative efforts. ReBoost and ClearLife were distributed nationwide via retail and internet sales on 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 immuno-compromised population. To date, MediNatura has not received any reports of adverse events related to this recall.

ReBoost Nasal Spray 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 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 homeopathic 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 20mL 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.

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medinatura-new-mexico-inc-expands-voluntary-nationwide-recall-reboost-nasal-spray-and-include