A batch of Labetalol 200mg tablets has been recalled as they are incorrectly labelled as 100mg tablets on the foil blister packaging.
But the Medicines Healthcare Products Regulatory Agency (MHRA) said that the actual tablets were 200g strength, consistent with the information on the outside of the box.
Pharmacists have been instructed to immediately stop supplying batch 221345, which was first distributed in May, and to quarantine all remaining affected stock and return it to the supplier.
And patients were told to contact their pharmacist if they had an incorrectly labelled pack or if they have any concerns.
If patients present with the incorrectly labelled aluminium foil blister, pharmacy teams should ‘exercise their professional judgement to supply the correct pack’, noted the MHRA.
And the MHRA added that if the prescription was written within six months, pharmacists could arrange for the dispensing of a pack that does not contain the incorrect blister foil labelling.
If the prescription was issued more than six months ago, the MHRA said that patients may need to seek advice from their GP for a further prescription.
And the MHRA told patients to seek immediate medical advice if they had accidentally taken too many tablets, bringing any remaining tablets and information with them.
Symptoms of Labetalol overdose include low blood pressure (hypotension), slower heartbeat (bradycardia), difficulty in breathing or wheezing (bronchospasm), drowsiness, confusion, seizures, hallucinations, and dilated pupils.
Labetalol, a beta blocker, is used to treat high blood pressure (hypertension), including in pregnancy, and to prevent chest pain caused by angina.
The number of medicines recalls has increased in recent years, leading to the Association of Independent Multiple Pharmacies (AIMp), to call for an inquiry into the cause of the issue.
MHRA figures suggest an average of 55-60 medicine recalls or notifications have been issued each year since 2019, compared to an average of 20-30 between 2015 and 2019.
These figures include a range of notifications – from notices about incorrect patient information leaflets, to recalls for medicines defects and risk of patient harm – and may be relevant to both hospital and community pharmacy.
The MHRA said that there had been an increase in packaging and labelling errors that often give rise to a Class 4 Alert, which suggests ‘caution in use’. But it said there was ‘no established reason’ for the increase.