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US recalls nasal spray over mold contamination, consumers at risk
US recalls nasal spray over mold contamination, consumers at risk of ‘fever, swollen sinuses, headaches, face pain’
United States recently recalled a nasal spray citing risk to potential "life-threatening infections." One lot of ReBoost Nasal Spray, which is labelled as homeopathic drug, was recalled by its manufacturer MediNatura New Mexico Inc.
This spray which is widely used to relieve nasal congestion, sinus headache and pressure, postnasal drip, sneezing, runny nose and nasal itching temporarily came under radar after the product was found to contain yeast or mold and microbial contamination. The US Food and Drug Administration (FDA) announced on 10 December that the contaminated medicine contains “one species identified as Achromobacter, at levels above specifications.”
Notifying that the spray has been recalled, the FDA in a statement said, “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.” Although the spray poses a risk to immuno-compromised population, but its manufacturer has not received any reports of adverse events related to this recall as of 10 December, the FDA said.
Distributed across the nation through retail and internet sales network, the recalled product is packaged in a 20mL bottle. Carrying the unique 10-digit National Drug Code (NDC) number 62795-4005-9 and the unique 12-digit Universal Product Code (UPC) number 787647 10186 3, the product was made available in a white and yellow carton packaging.
“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 recall@medinatura.com to arrange for a refund. Consumers who purchased the product at retailers should return it to the place of purchase,” the FDA circular said.
This particular withdrawn drug includes 224268 lot number and has an expiration date of 12/2027. Described as “Nasal spray, 0.68 fl oz,” the ReBoost drug.
What are the side-effects of using this recalled nasal spray?
The Hawaii State Department of Health also announced the recall and listed some side-effects of using this nasal spray, including symptoms of “fever, swollen sinuses, headaches, face pain or pressure and facial numbness.”It urged consumers to "contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product." Advised customers to “immediately discontinue” use of the product, the FDA said that if in case the administration of this drug caused adverse reactions or quality problems, then customers must report this issue to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
According to the website of Albuquerque-based homeopathic company, ReBoost Nasal Spray is a homeopathic spray containing the herb echinacea and other natural ingredients.
Source: LiveMint
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