Class 2 Medicines Recall: Cold & Flu Relief Capsules (GSL) – Various Liveries, Wrafton Laboratories Limited (trading as Perrigo), EL (21)A/28

Perrigo are recalling certain batches in various liveries as the leaflet and carton incorrectly states that for adults, elderly and children 12 years and over, the dose should be 2 capsules every 4 to 6 hours as required, up to a maximum of 12 capsules in any 24 hour period.

SPS commentary:

As each capsule contains 300mg of paracetamol, 12 capsules would equate to 3.6g/day. This exceeds the MHRA recommended maximum dose for 12-15 year old’s, which is 3g/day. The correct posology instructions should state the following:

  • Adults and children 16 years and over: 2 capsules every 4 to 6 hours as required, up to a maximum of 12 capsules (6 doses) in any 24 hour period.
  • Children aged 12 to 15 years: 2 capsules every 4 to 6 hours as required, up to a maximum of 8 capsules (4 doses) in any 24 hour period.

Medicines and Healthcare products Regulatory Agency

Resource links:

MHRA press release