2024.05.02 Recall: Restore Sinus Spray
02 May 2024
The following notice has been issued by the Office for Product Safety and Standards.
Product
Restore Sinus Spray
Type
Chemical Products - Nasal Spray
Brand
Restore
Country of origin
United States
Product description
A white 30 ml bottle of sinus spray designed to help clean and hydrate nasal passages. Packaged in a rectangular white cardboard box.
Sales period
June 2017 to September 2019
Affected UK batches (order number - lot number)
518151 - 2108021HFA
518150 - 2108021HFA
480659 - 210726SS01
480657 - 210726SS01
443688 - 210726SS01
378470 - 210303SS01
326462 - 201009SS01
293015 - 200724SS011
283545 - 200430SS011
276321 - 200430SS011
276296 - 200430SS011
262086 - 200402SS011FC
255069 - 200311SS11-GM
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.
Corrective action
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].
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