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Medicines recallMHRA

Oestrogel Pump-Pack 750 micrograms/actuation Gel (estradiol) recalled over a quality concern

Medicine quality concernMedium riskClass 3

Besins Healthcare (UK) Ltd has informed the MHRA that a defective pump system was detected in two batches of Oestrogel Pump-Pack 750 micrograms/actuation Gel.

Check your product

Only products that match these details are covered. Have your pack in front of you.

7 identifiers listed for this notice.

  • Oestrogel Pump-Pack 750 micrograms/actuation Gel (estradiol) 1

    Batch codePrinted on the pack, often next to the date mark. It may start with L or LOT.
    • 74800
    • 74830
    Product licenceThe PL number on the carton.
    • PL 28397/0002
    ExpiryOn the carton, blister or label.
    • 31/07/2026
    • 31/08/2026
    First distributedOn the product, its label or its packaging.
    • 06/11/2023
    • 08/11/2023

What to do now

Affected batches of Oestrogel Pump-Pack 750 micrograms/actuation Gel (estradiol) are subject to a recall or defect notice.

  1. Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect.
  2. Compare the batch number printed on the box or label with the batches listed here.
  3. If your pack is affected, take it to your pharmacy or contact the prescriber for a replacement.
  4. Any side effect you think is linked can be reported through the Yellow Card scheme.

Why it matters. The MHRA classifies medicines recalls from Class 1 (most serious) to Class 4 (caution in use). The notice below sets out the details.

Symptoms and when to get help

Look out for

  • a side effect you have not had before
  • your condition not being controlled as well as usual

Get help urgently

  • signs of a severe allergic reaction, such as swelling of the face or throat or difficulty breathing — call 999
  • if you feel unwell and are worried, speak to a pharmacist, your GP or NHS 111

This is general information based on NHS public guidance, not medical advice. In an emergency call 999. For urgent advice use NHS 111 (NHS 24 on 111 in Scotland) or, in Northern Ireland, your GP or out-of-hours service.

Replacements and prescriptions

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement.

If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

From the official notice

Published by the Medicines and Healthcare products Regulatory Agency (EL(24)A/09). Quoted as issued.

Summary

Besins Healthcare (UK) Ltd has informed the MHRA that a defective pump system was detected in two batches of Oestrogel Pump-Pack 750 micrograms/actuation Gel.

The risk

MDR number MDR 333-02/24 Company name

Advice for healthcare professionals

Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process. Follow your company’s returns procedure through your wholesaler to arrange a credit note or contact Besins (see Further Information below for contact details).

If a patient presents with a defective pump from these batches a replacement product will be required. 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.

The majority of patients who have received this product will be entitled to free prescriptions 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.

Besins Healthcare (UK) Ltd has confirmed that all other batches are unaffected and that there is no impact on supply.

Patients who experience issues with a pump from the batches specified in the table should return the defective pumps to their pharmacy. As this is a prescription only medicine, a new prescription will be required for the dispensing of a replacement product. Patients with a HRT pre-payment certificate 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.

No further action is required by patients as this is a Pharmacy and Wholesaler level recall. Where the pump is functioning correctly, patients should continue to take medicines from these batches as prescribed by your healthcare professional.

Patients who experience adverse reactions, defective medicines or have any questions about the medication, should seek medical attention and report their symptoms to pharmacovigilance@besins-healthcare.com . Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .

Advice for patients

Patients who experience issues with a pump from the batches specified in the table should return the defective pumps to their pharmacy. As this is a prescription only medicine, a new prescription will be required for the dispensing of a replacement product. Patients with a HRT pre-payment certificate 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.

No further action is required by patients as this is a Pharmacy and Wholesaler level recall. Where the pump is functioning correctly, patients should continue to take medicines from these batches as prescribed by your healthcare professional.

Patients who experience adverse reactions, defective medicines or have any questions about the medication, should seek medical attention and report their symptoms to pharmacovigilance@besins-healthcare.com . Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme .

Open the MHRA notice

Questions

Why has Oestrogel Pump-Pack 750 micrograms/actuation Gel (estradiol) been recalled?

Affected batches of Oestrogel Pump-Pack 750 micrograms/actuation Gel (estradiol) are subject to a recall or defect notice. The MHRA classifies medicines recalls from Class 1 (most serious) to Class 4 (caution in use). The notice below sets out the details.

How do I know if my medicine is affected?

Compare the batch code, product licence, expiry and date code on your pack with the details listed under “Check your product” on this page. Only items that match are covered by the notice.

What should I do now?

Do not stop taking a prescribed medicine without advice: missing doses can be more dangerous than the defect. Compare the batch number printed on the box or label with the batches listed here.

Do I need a new prescription?

Talk to the pharmacist who dispensed the medicine. They have the batch information and can arrange a replacement. If you bought it over the counter, return it to the pharmacy or shop for a refund or replacement.

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