MHRA Class 3 Medicines Recall: Evorel Sequi (Theramex HQ UK Ltd)

MHRA Class 3 Medicines Recall: Evorel Sequi (Theramex HQ UK Ltd)

Drug alert number: EL (24)A/41

Date issued: 12 September 2024

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 3 medicines defect information notice for: Evorel Sequi (Theramex HQ UK Ltd)

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 112,728 packs. So far 19 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 supplier’s approved process.

If a patient presents with the incorrect patches, a replacement pack will be required. Theramex has confirmed that all other batches are unaffected and that there is no impact on supply. The Department of Health and Social Care (DHSC) has confirmed that, as this is a prescription only medicine, a new prescription will be required for the dispensing of a replacement product.

Some patients who have received this product will be entitled to free prescriptions through existing exemptions, or have arrangements in place for a HRT pre-payment certificate and therefore a new prescription will not incur any additional costs. Where patients pay for NHS prescriptions, a charge for the new prescription will apply; patients may contact the Defective Medicines Reporting Centre if further information is required.

View full alert here.

Advice for patients

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 for further advice and arrangement for dispensing of a replacement product.

Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should be reported via the MHRA Yellow Card scheme.

Further Information

For medical information enquiries please contact the Theramex Medical Information Department via medinfo.uk@theramex.com or call 0333 009 6795.

For stock control enquiries please contact Alliance Customer Services Team on 0330 100 0448.