Publication #8087

Reference
Drug alert 09/2024
Name
Drug alert class 3 – 09 2024 – Class 3 medicines recall – action within 5 days – Besins Healthcare (UK) Ltd Oestrogen pump-pack 750 mcg/actuation gel (Estradiol)
Categories
Scottish Government Drug Alerts
Organization
Scottish Government Health and Social Care Department
Keywords
NHS Scotland Drugs Safety Risks Pharmaceutical Industry Medicines Recall
Description
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 product pumps are subject to mechanical faults which result in the failure to dispense the product and in some cases, the detachment of the pump from the container. It is estimated that 11% of units across the two batches could be affected by the defect.
Where the pump is functioning, there is no impact on the quality or safety of the Gel and therefore this is not a patient level recall.

Contact Name
Irene Fazakerley
Contact Address
Contact Phone

Created
2024-03-19 12:59:34


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