Oestrogel recall: faulty pump is affecting two batches

What’s happened?

Besins Healthcare (UK) Ltd, the manufacturer of Oestrogel, has informed the Medicines and Healthcare products Regulatory Agency (MHRA) that a faulty pump system has been detected in two batches of its Oestrogel pump bottles.

Is my Oestrogel affected?

Two batches of Oestrogel Pump-Pack 750 micrograms/actuation Gel have been affected. These are:

• Batch no: 74800, Expiry Date 31/07/2026, first distributed 06/11/2023
• Batch no: 74830, Expiry Date 31/08/2026, first distributed 08/11/2023

Not all products in the batch are affected – it’s estimated that 11% of the pump-action bottles could be affected by the defect.

What’s the problem?

The product pumps are subject to mechanical faults, which means they can fail to dispense the gel and, in some cases, detach from the container. Where the pump is functioning, there is no impact on the quality or safety of the gel.

Will my Oestrogel still work?

If you have Oestrogel from either of the two batches and the pump mechanism is working, there is no impact on the quality or safety of the gel, and these are not being recalled from patients. If your pump is working, you can continue to use your gel as prescribed by your healthcare professional.

What if my pump isn’t working?

If you experience issues with a pump from the either of the two batches specified, you should return the defective pump to the pharmacy.

Will I get a replacement?

Oestrogel is a prescription only medicine so a new prescription will be required for the dispensing of a replacement product. If you have an HRT pre-payment certificate, you will not have to pay for the replacement. If you pay for NHS prescriptions, a charge for the replacement prescription will be made.

Could this cause a shortage?

Besins Healthcare has confirmed that all other batches of Oestrogel are unaffected and that there is no impact on supply. No other action is needed as this recall is happening at a pharmacy and wholesaler level.

What’s the usual reporting system?

If you experience adverse reactions, defective medicines or have questions about the medication, the MHRA advises patients to 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 at yellowcard.mhra.gov.uk.