The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an urgent alert following a labelling error on a batch of the common blood pressure medicine lercanidipine (lercanidipine hydrochloride).
The alert comes after Recordati Pharmaceuticals Limited, the manufacturer, informed the MHRA of an error in the strength of the product printed on some sides of the product carton for one batch.
“The packs are incorrectly labelled as 10mg on some sides of the pack when they are 20mg tablets.
The correct strength (20mg) is printed on the top of the carton and on the blister strips.”
The error is limited to batch number MD4L07, with an expiry date of 01/2028.
Patients who take lercanidipine are advised to immediately check the batch number printed on the foil of the blister strips.
Advice for patients
Patients prescribed 10mg tablets and have received tablets with this batch number are advised to contact their pharmacist or GP immediately, or call NHS 111 if they cannot reach a healthcare professional.
If a patient must take their next dose before speaking to a healthcare professional, they should:
1.Verify the strength of the tablets is 20mg from the information on the foil of the blister strips
2.Remove one tablet from the blister
3.Locate the break line on the tablet
4.Snap the tablet in half across the break line and take half of the tablet. This is permitted for the 20mg tablets and is in line with information included in the patient information leaflet.
Patients prescribed 20mg tablets should verify the strength by checking the information on the foil of the blister strips and continue taking the tablets as directed by their doctor.
MHRA has cautioned patients not to stop taking their medicine without consulting their healthcare provider.
Patients concerned about the strength of the medication should check it with their dispensing pharmacy.
Anyone who believes they may have accidentally taken a higher dose than prescribed is urged to speak to a pharmacist, contact their GP, or call NHS 111 for advice.
“Patient safety is our top priority,” said MHRA Chief Safety Officer, Dr Alison Cave, asking patients to check their medicine packaging and follow their advice.
Pharmacists are also being asked to stop supplying medicine from the affected batch and to return it to the supplier.
Dr Cave has also urged patients to report any suspected adverse reactions via the MHRA’s Yellow Card scheme.
Recordati Pharmaceuticals Limited has initiated a recall of the specified batches as a precautionary measure.
