Product Recall: Restore Sinus Spray (2404-0136)
Product Recall for Restore Sinus Spray presenting a risk of microbiological contamination.
Summary
Product: Restore Sinus Spray
Hazard: The product presents a microbiological risk as it is contaminated with bacterium.
Corrective action: The product has been recalled from end users.
Product information
| Type | Chemical Products - Nasal Spray |
|---|---|
| Brand | Restore |
| Sales Period | June 2017 to September 2019 |
| Country of Origin | United States |
| Product Description | A white 30ml bottle of sinus spray designed to help clean and hydrate nasal passages. Packaged in a rectangular white cardboard box. |
| Product Report and Image |
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 sinusrecall@detoxpeople.eu.
Additional information
PSD number: 2404-0136
Notified by: Local Authority Trading Standards