People who have purchased Boots Paracetamol 500mg Tablets 16s
(Item code 81-99-922, Batch 241005, Expiry date 12/2029) are
advised to stop using the product immediately and return it to a
Boots store for a full refund, because of a packaging
error.
The Medicines and Healthcare products Regulatory Agency (MHRA)
has issued a medicines recall alert
due to a packaging error where the foil blister inside the carton
incorrectly states ‘Aspirin 300mg Dispersible Tablets' instead of
‘Paracetamol 500mg Tablets'. 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.
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. If affected, they should stop using the
product immediately and return it to a Boots store for a full
refund, with or without receipt.
Boots Paracetamol 500mg packs, with the batch number 241005,
should not be kept at home, even if the error is known, as this
could lead to confusion and an incorrect dose being taken. Anyone
who has purchased this product for someone else should inform
them as soon as possible.
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.
Advice for Members of the Public:
-
Stop using the impacted batch immediately and return this to
Boots stores where a full refund will be provided with or
without a receipt.
-
Aspar Pharmaceuticals Limited and The Boots Company PLC have
confirmed that the tablets in the blister packs are
Paracetamol 500mg and not aspirin. If you have taken tablets
from this batch and have any additional questions, please
seek advice from your pharmacist or other relevant healthcare
professional.
-
Patients who experience any suspected adverse reactions or
have any questions about the medication should seek medical
attention. Any suspected adverse reactions should also be
reported via the MHRA Yellow Card
Scheme.
Notes to Editors:
-
The MHRA has issued a recall notification for a specific
batch of Boots Paracetamol 500mg Tablets due to a packaging
error: Class 2 Medicines
Recall Notification: Boots Paracetamol 500 mg tablets
(16s)
-
This recall affects 119,964 packs of Boots Paracetamol 500mg
(16s)
-
The Medicines and Healthcare products Regulatory Agency
(MHRA) is responsible for regulating all medicines and
medical devices in the UK by ensuring they work and are
acceptably safe. All our work is underpinned by robust and
fact-based judgements to ensure that the benefits justify any
risks.
-
The MHRA is an executive agency of the Department of Health
and Social Care.
-
The Yellow Card
Scheme is MHRA's system of monitoring the safety of
medicines in the UK and it acts as an early warning system to
identify new, and strengthen existing, safety information
about medicines. Yellow Cards are used alongside other
scientific safety information to help MHRA to take action, if
necessary, to make changes to the warnings given to people
taking a medicine or review the way the medicine is used to
maximise benefit and minimise the risk to the patient.