Class 4 drug alert – Caution in Use – Paracetamol solution for infusion 10mg/ml

01 Mar 2019

A Class 4 drug alert, intended for healthcare professionals, has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for paracetamol solution for infusion 10mg/ml manufactured by Actavis Group PTC ehf and Accord Healthcare Limited.

DRUG ALERT

Class 4 drug alert – Caution in Use

Ref: EL (19)A/06

Date 28 February 2019

 Paracetamol solution for infusion 10mg/ml

(Manufactured by Actavis Group PTC ehf and Accord Healthcare Limited)

PL 30306/0391 (Actavis Group PTC ehf)

PL 20075/0701 (Accord Healthcare Limited)

A Class 4 drug alert, intended for healthcare professionals, has been issued by the Medicines & Healthcare products Regulatory Agency (MHRA) for paracetamol solution for infusion 10mg/ml. The drug alert applies to all unexpired batches of the product currently on the market with the above PL numbers.

An error is present in the dosage information table of the patient information leaflet (PIL) which is jointly shared between the 50ml and 100ml vial. The error is applicable to the 50ml vial size, and as it is not currently marketed, there is a chance that the 100ml vial (restricted for use in patients weighing 33kg or more), is being used in patients weighing less than 33kg.

The table below shows the incorrect and correct PIL information:

Incorrect version of the PIL Corrected version of PIL
Maximum volume of solution for administration to babies and infants weighing 10kg or less is 75ml Maximum volume of solution for administration to babies and infants weighing 10kg or less is 7.5ml

The PIL has been corrected and is accessible on the eMC website.

Advice for pharmacists and their teams

  • Ensure the correct PIL is given when dispensing the affected products
  • Inform relevant contacts with regards to this drug alert

Further information can be found on the MHRA section on the GOV.UK website.

Produced by the NPA Pharmacy team February 2019.