Medicine recalls
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| The United Kingdom: Class 3 Medicines Recall: Urospir 50mg/5ml Oral Solution |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Rosemont Pharmaceuticals Limited is recalling a single batch of Urospir 50mg/5ml Oral Solution (spironolactone) (batch number: 1014870) as a precautionary measure. The recall is due to errors in some of the dose calculation in millilitres being stated incorrectly in section 4.2 of the SmPC (Summary of Medicinal Product Characteristics) and section 3 of the PIL (Patient Information Leaflet or package insert). The product correctly contains 50mg/5ml and the pack (carton) is labelled correctly. This recall is at pharmacy and wholesaler level.
The product is indicated for congestive cardiac failure, hepatic cirrhosis with ascites and oedema, malignant ascites, nephrotic syndrome, diagnosis and treatment of primary aldosteronism.
For products that have already been dispensed to patients and where prescribers have used the Rosemont SmPC for dose considerations by volume; these prescriptions should be reviewed. This should only impact prescriptions where the volume (ml) has been written on the prescription, which could have led to an error in dose, e.g. incorrectly written as 100mg daily (20ml), whereas it should state 100mg daily (10ml). Prescribers (GPs, Independent Prescribers Nurse Prescribers and all other relevant prescribers) should ensure that the correct dose had been requested. Should there be concern that a patient has been given a higher than required dose, the physician should review the case and contact the patient where appropriate.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-3-medicines-recall-urospir-50mg-slash-5ml-oral-solution-el-25-a-slash-14
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Thursday, Apr 3, 2025
Issued at HKT 17:15
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