GovWire

MDR number

MDR 240-08/23

Company name

Theramex HQ UK Ltd

Product name

Evorel Sequi PL 49105/0010

SNOMED Code

3217311000001104

Active Pharmaceutical Ingredient: each pack of Evorel Sequi contains eight patches; four (4) Evorel 50 patches (containing estradiol only) and four (4) Evorel Conti patches (containing estradiol and norethisterone).

Brief description of the problem

Theramex has informed the MHRA that some cartons of Evorel Sequi contain the incorrect combination of patches. An error at the packaging site means that a limited number of packs have the incorrect combination of Evorel 50 and Evorel Conti patches. Only the batch listed in this notification is affected. The remainder of the batch is being recalled as a precautionary measure. The batch is comprised of 150,132 packs. So far 24 packs have been confirmed to contain the incorrect combination and the investigation has concluded that the issue is limited to a small number of packs only.

Advice for healthcare professionals

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your suppliers approved process.

If a patient presents with the incorrect patches, they should be dispensed a correct pack from another batch. Theramex has confirmed that all other batches are unaffected and that there is no impact on supply.

For prescriptions written within the last 6 months, check the pack being returned by the patient and the dispensing record (Summary Care Record may be checked with the patients consent). Following advice from the Department of Health and Social Care, this is considered a correction to the original prescription and a further prescription would not be necessary. Follow your companys returns procedure through your wholesaler to arrange a credit note or contact Theramex (see Further information below for contact details).

Advice for patients and carers

Patients who may have received the impacted batch of Evorel Sequi should consider the following information:

• Check the contents of your pack to ensure that it contains four (4) Evorel 50 patches and four (4) Evorel Conti patches. The packaging is clearly labelled with the medication names.
• If you have received four (4) of each patch, please continue to take the medicine as prescribed by your healthcare professional. You do not need to take any action.
• If you do not have 4 of each patch, please contact your pharmacist. If the prescription was written within the past 6 months, the pharmacist will arrange for the dispensing of a correct pack from another batch. Alternatively, contact your GP directly as a new prescription may be required.

Patients who experience 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.

Further Information

For medical information enquiries please contact the Theramex Medical Information Department on 033 3009 6795 or via email: medinfo.uk@theramex.com

For pharmacy stock control enquiries please contact Alliance Customer Services Team on 020 3962 5555.

Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.

Yours faithfully

Telephone: +44 (0)20 3080 6574

Email: DMRC@mhra.gov.uk

Download document

Class 3 Medicines Recall: Theramex HQ UK Ltd, Evorel Sequi, EL (23)A/34