Product recall cold and flu capsules – Wrafton Laboratories

11th November 2021

 

We would like to inform you that eleven retailers from around the UK are being asked to recall certain batches of cold and flu capsules produced by Wrafton Laboratories Limited (trading as Perrigo) due to a mistake on the leaflet and carton that states children aged 12 to 15 years can take a maximum of up to 12 capsules (3.6 grams of paracetamol per day) in any 24 hour period. This labelling is correct for adults aged 16 years and over, but not for children aged 12 to 15 years old.

 

The correct labelling from the company for these products should state a maximum daily dose of 8 capsules per day (2.4 grams of paracetamol) for 12 to 15 year olds, which is slightly lower than the recommended daily dose from the MHRA of 3g in this age group. The risk to 12 to 15 year olds from taking the incorrect daily dose is very low and there is no evidence of any harm.

 

For batch numbers affected at retail and wholesale level, please see the Class 2 recall notice.

 

This product has been taken off shelves while the labelling is updated.

 

Advice for healthcare professionals

  • Stop supplying the above batches immediately.
  • Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
  • If a child aged 12 to 15 years has used this product for a short period of time and has not experienced any side effects, please offer them reassurance that there is no evidence of harm.
  • Report any suspected side effects via the Yellow Card Scheme.

 

Please refer to the alert and Press release for further information.

 

We would be grateful for your help in disseminating this safety message further through your networks and contacts. 

 

If you have any queries, please email MHRACustomerServices@mhra.gov.uk