Restore Sinus Spray — microbiological risk

Hazard

The product has been identified as presenting a microbiological risk as testing found the product to contain microbial contamination identified as Microbacterium sp, Fictibacillus sp, Bacillus sp, (primarily B. malikii), and Paenibacillus sp. In the population most at risk, patients or individuals who recently underwent nasal or sinus surgery, 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. The product does not meet the requirements of the General Product Safety Regulations 2005.

Remedy

The product has been recalled from end users. Consumers in possession of the product are advised to promptly inspect any Sinus products you have and stop using it. If you would like to be contacted further regarding product you still have, please take a picture of the batch number on the bottom of the bottle and then dispose of the product accordingly. Please send your image and order information (if available) to [email protected] .

Product recall

Measures taken

• Recall of product from end users

Product description

A white 30ml bottle of sinus spray designed to help clean and hydrate nasal passages. Packaged in a rectangular white cardboard box.