A Third of a Million Revolax Dermal Fillers Urgently Recalled
The manufacturers of Revolax have urgently recalled well over a third of a million products in The UK and Denmark – the vast majority of them in Britain.
An “Urgent Field Safety Notice” has been issued to the medicines police, The Medicines and Healthcare products Regulatory Agency (MHRA), by ACROSS in the UK for 324,932 Revolax Fine with lidocaine, Deep with Lidocane and Sub-Q with Lidocaine issued between 29th November, 2018 and 20, October, 2020.
The Medicines and Healthcare products Regulatory Agency is responsible for ensuring that medicines and medical devices work and are acceptably safe.
There is no suggestion that the products are unsafe but the recall has been performed because the required CE registration was incorrect for sale in Europe.
The Field Safety Notice states that the recall has been issued because sales in the EU markets is not appropriate without CE certification.
It also states: “There is not any additional risks or hazards if a user was to use product that was not supported by a valid CE certificate.”
Risks are listed as “improbable”.
But all products must be sent back to the manufacturer.
The process is as follows:
1. The FSN will be notified to distributors by the manufacturer using a ‘Distributor Reply Form’ and ‘Customer Reply Form’.
2. Distributor should check the inventory of the affected products and LOTs and check the quantities that has been released to the customers.
3. Distributor should notify all affected customers this FSN using the ‘Customer Reply Form’.
4. All affected products must be recalled from customers and documented using the ‘Customer Reply Form’. All such recalled products should be reconciled with the distributor’s own inventory.
5. Distributor must return all affected products to manufacturer.
This procedure should be done within 2 months.
The products affected all have the CE mark CE 1023.