Two batches of Oestrogel Pump-Pack 750 micrograms/actuation Gel (estradiol) produced by Besins Healthcare (UK) Ltd have been recalled from pharmacies over issues with the pump mechanism.
More than one in 10 (11%) of the pumps within these batches may be faulty, resulting in failure to dispense the product and in some cases the pump becoming detached from the bottle, the Medicines and Healthcare Products Regulatory Agency (MHRA) has said.
The product contains a form of the female hormone oestrogen and can be applied to the skin to relieve symptoms of the menopause such as hot flushes, night sweats, vaginal dryness and help to prevent osteoporosis.
Pharmacies have been instructed to stop supplying batch numbers 74800 and 74830 immediately; to quarantine all remaining stock and return it to the supplier; and to arrange a credit note with the wholesaler or contact Besins.
The batches are not being recalled from patients as there is no impact on the quality or safety of the gel, but if patients present at a pharmacy with a defective product a replacement will be required, the MHRA said.
Patients will require a new prescription for the dispensing of a replacement product, the Department of Health and Social Care (DHSC) has confirmed.
Where patients pay for NHS prescriptions, they will be charged for this, but since the majority receiving this product are entitled to free prescriptions or have a HRT pre-payment certificate (PPC), no charge will be incurred for most patients, the MHRA said.
Patients may contact the Defective Medicines Reporting Centre if further information is required, the regulator added.
Over the last year, pharmacy bodies have spoken out against an increasing number of medicine recalls and notifications, highlighting the ‘unfunded’ workload they place on pharmacy teams already under pressure.
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