Drug recall: This Nasal Spray recalled due to Microbial Contamination

The affected lots were distributed to wholesale and retail outlets, as well as sold directly to consumers online.

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Drug recall
Drug recall

Last Updated on October 2, 2024 by The Health Master

Drug recall

Drug recall: Biomic Sciences is voluntarily recalling all lots of ION Sinus Support, ION Sinus, and Restore Sinus Spray products to the consumer level.

DA testing found the product to contain microbial contamination identified as Microbacterium sp., Fictibacillus sp., Bacillus sp., (primarily B. malikii), and Paenibacillus sp (these microorganisms are generally non-pathogenic).

Risk Statement:

In the population most at risk, patients or individuals who recently underwent nasal or sinus surgery, there is a reasonable probability that the use of the affected product could potentially result in severe or life-threatening adverse events such as bacteremia or fungemia, invasive bacterial or fungal rhinosinusitis, or disseminated fungal infection.

To date, Biomic Sciences has not received any reports of adverse events related to this product.

The product is used as a nasal rinse and is packaged in individual boxes of one or two nasal spray dispensers. All lots of the of the following products are covered by this recall:

Product NameSales Period
ION Sinus SupportSeptember 2021 through September 20, 2023
ION SinusSeptember 2019 through September 2021
Restore Sinus SprayJune 2017 through September 2019

The affected lots were distributed to wholesale and retail outlets, as well as sold directly to consumers online.

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

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