Medicine recalls
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| The United Kingdom: Class 3 Medicines Recall: Besins Healthcare (UK) Ltd, Oestrogel Pump-Pack 750 micrograms/actuation Gel (estradiol) |
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The Medicines and Healthcare products Regulatory Agency (MHRA) announces that 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 (estradiol) (batch number: 74800, 74830). 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.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-3-medicines-recall-besins-healthcare-uk-ltd-oestrogel-pump-pack-750-micrograms-slash-actuation-gel-estradiol-el-24-a-slash-09
In Hong Kong, Oestrogel Gel 0.06% (HK-34023) is a pharmaceutical product registered by Besins Healthcare China Investments Limited (Besins). The product is a prescription-only medicine. As confirmed with Besins, Oestrogel Gel 0.06% (HK-34023) is supplied in tube, which is different from the pump-pack product recalled in the United Kingdom, and the affected batches have not been imported into Hong Kong.
Ends/Wednesday, Mar 20, 2024
Issued at HKT 15:00
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