Class 4 MHRA Drug Alert – Paracetamol Infusion (Accord)

Class 4 MHRA Drug Alert – Paracetamol Infusion (Accord)

February 28, 2019

Drug Alert No: El (19) a/06
Date Issued: 28th February 2019

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 4 drug alert for Paracetamol 10mg/ml Solution for Infusion (Accord).

Actavis Group PTC ehf, PL 30306/0391

Accord Healthcare Limited, PL 20075/0701

Accord Healthcare Limited have informed MHRA, that there is an error in the Patient Information Leaflet (PIL).

The PIL applies to the 50ml and 100ml vials.

While the error applies to the 50ml vial which isn’t currently marketed, and the 100ml vial is restricted for use in adults, adolescents and children weighing more than 33kg, the possibility cannot be ruled out that it is being used for the treatment of term newborn infants, infants, toddlers and children weighing 33kg or less. All unexpired batches of the product fall within the scope of this alert.

Community pharmacy teams should replace the incorrect PIL which contains incorrect volumes for administration, with the correct version which can be downloaded here.

Distribution of affected batches will cease once corrected stock is available. It is anticipated that new batches will be available during Q2 2019.

View the full alert here

For stock control enquiries, please contact Accord Customer Services Team on 0800 373573

For medical Information enquiries, please contact Accord Medical Information Department on
01271 385257

 

 



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