This follows an error in the strength of the product printed on some of the sides of the pack. The error is limited to one batch of the medicine only.
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.
An alert, has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA) today.
Patients prescribed 10mg tablets
Patients prescribed 10mg tablets and have received tablets with this batch number should contact their pharmacist or GP immediately.
If the GP or pharmacist cannot be reached, patients should call NHS 111 for advice on continuing their medication.
If a patient cannot speak to a healthcare professional before they are due to take their next dose, they should:
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verify the strength of the tablets is 20mg from the information on the foil of the blister strips
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remove one tablet from the blister as normal
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locate the break line on the tablet
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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 (where it states ‘The tablet can be divided into equal doses’). This is a temporary measure until you can talk to your pharmacist or doctor.
Patients prescribed 20mg tablets
Patients who were prescribed 20mg tablets should verify the strength of the tablets by checking the information on the foil of the blister strips prior to taking the tablet. Patients should continue to take the tablets as prescribed by their doctor.
Patients should not stop taking their medicine without consulting their healthcare provider. Patients who are concerned about the strength of the medication they have received should check it with their dispensing pharmacy.
Patients concerned they may have accidentally taken a higher dose of the medication than they were prescribed should talk to a pharmacist, their GP or call NHS 111.
Patients who experience side effects or have any questions about the medication should seek medical attention. Any suspected side effects should also be reported via the MHRA Yellow Card scheme.
Dr Alison Cave, MHRA Chief Safety Officer said:
Patient safety is our top priority. We ask patients to check their medicine packaging and follow our advice.
Healthcare professionals such as pharmacists are also being asked to stop supplying medicine from the affected batch and to return it to the supplier.
Please report any suspected adverse reactions via the MHRA’s Yellow Card scheme.
The alert was issued after the manufacturer, Recordati Pharmaceuticals Limited, informed the MHRA of an error in the strength of the product printed on some sides of the product carton. Recordati Pharmaceuticals Limited is initiating a recall of the specified batches as a precautionary measure.
Notes to editors
- You can find local pharmacy opening times by using the NHS’s Find a Pharmacy page.
- You can find which pharmacies are open by searching for Easter opening times online, contacting your local pharmacy or calling 111.
- Patients who may have accidentally taken a higher dose of the medication than they were prescribed should talk to a pharmacist, their GP or call NHS 111.
- Each of the packs affected by the recall contains 28 tablets. 7769 packs of the tablets have been distributed.
- 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 judgments to ensure that the benefits justify any risks.
- The MHRA is an executive agency of the Department of Health and Social Care.
- For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.
