Urgent recall of cold and flu medication over labelling error

Some retailers in the UK are recalling batches of cold and flu capsules over a mistake on the packaging. The label overstated what the maximum safety dose for children should be.

Low Risk

The capsules, manufactured by Wrafton Laboratories and sold under the name Perrigo, were sold by some 11 retailers in the UK including Boots, Tesco, Wilko, Spar, Waitrose, Aldi, Asda, Superdrug, Sainsbury’s, Lloyds and Morrisons.

According to the Medicines and Healthcare products Regulatory Agency (MHRA), the risk to consumers is low. MHRA chief safety officer Dr Alison Cave said:

I want to reassure people that while this recall is aimed at retail level only, patient safety is at the centre of all our decision-making.

In issuing the recall, the MHRA said the packaging incorrectly advises that children aged 12 to 15 can take a maximum of up to 12 capsules (3.6g of paracetamol per day) in any 24-hour period, instead of a maximum daily dose of eight capsules per day (2.4g of paracetamol).

The instructions on the packaging meant the dosage for children in this age range was higher than the MHRA’s recommendation that they should take 3g of paracetamol in a day at most.

Correct Label

According to the MHRA, a pack of Perrigo cold and flu medication has 16 capsules containing 300mg of paracetamol, which provides two days of treatment at the maximum dose.

The MHRA said the company is currently correcting its labelling and the products have been taken off shelves until this is completed.

In the meantime, it is advising the members of the public who may have these capsules at home, to adhere to the revised daily dosage recommendation for children. Dr Alison Cave said:

If you or your child are aged 12 to 15, have recently used these capsules and have not experienced any side-effects, there is no cause for concern. If you currently have one of these packets at home, please take note of the corrected dose in this age group and talk to your pharmacist if you are unsure of these changes.