April 7th 2025

By Ailsa Colquhoun

Alert: Urospir 50mg/5ml Oral Solution

One batch of Urospir 50mg/5ml Oral Solution is being recalled.

The affected batch is  

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.

Healthcare professionals are asked to quarantine all stock from this batch and return it to your supplier using your supplier’s approved process.

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. Further information is available online.  

Details of the errors in the SmPC have been outlined in Appendix 1 of the download document (incorrect doses marked in strikethrough, correct doses highlighted in yellow, bold and underlined).

Patients who are taking Urospir 50mg/5ml Oral Solution (spironolactone) should continue to take the medication.