The MHRA said people who have purchased Boots Paracetamol 500mg Tablets 16s (item code 81-99-922, batch 241005, expiry date 12/2029) were advised to stop using the product immediately and to return it to a Boots store for a full refund, because of the error.
The foil blister inside the carton incorrectly states ‘Aspirin 300mg Dispersible Tablets’ instead of ‘Paracetamol 500mg Tablets’, MHRA said.
The Boots Company PLC and the supplier, Aspar Pharmaceuticals Limited, have confirmed that the tablets in the blister packs are Paracetamol 500mg and not aspirin, and are conducting a full investigation into the issue.
MHRA said members of the public, including carers, should check if their pack has the batch number 241005, which can be found on the bottom of the box.
Dr Stephanie Millican, MHRA deputy director benefit risk evaluation, said: “Patient safety is always our priority. It is vitally important that you check the packaging of your Boots Paracetamol 500mg Tablets 16s, and if the batch number is 241005, you should stop using the product and return it to a Boots store for a full refund.
“If you are unsure which pack you have purchased or have taken Boots Paracetamol 500mg Tablets and experienced any side effects, seek advice from a healthcare professional. Please report any suspected adverse reactions via the MHRA’s Yellow Card scheme.
“If you have any questions or require further advice, please seek advice from your pharmacist or other relevant healthcare professional.”
The recall affects 119,964 packs of Boots Paracetamol 500mg (16s).
Bart Vansteenkiste, global sector manager – life sciences at Domino Printing Sciences, commented: “Labelling mistakes are an unfortunate and all too common reality across many industries and can have very dangerous repercussions.
“In this instance, the mistake was likely the result of human error – the outer packaging they used was correct, but the roll of pre-printed blister foils used was for a different product.
“This is an easy mistake to make when using pre-printed blister foils that typically all look very similar. Often, the only difference is the name of the medicine, making it relatively easy for operators to pick the wrong roll and mount it on a blister packaging machine.
“What many manufacturers may not know is that this type of error can be easily avoided by printing foils online rather than holding pre-printed stock.
“At Domino, we encourage our customers to start from blank foils and print the product information, batch code, and expiry dates online as part of the packaging process.
“As packaging lines in pharma go through a strict validation process, it is impossible to start packaging paracetamol and then print aspirin on the blister foil.
“We also recommend printing unique 2D codes on the blister packaging to allow hospital and healthcare staff to double check medicines before they are taken by a patient.”
