MHRA Class 3 Medicines Recall: Urospir 50mg/5ml Oral Solution

MHRA Class 3 Medicines Recall: Urospir 50mg/5ml Oral Solution

Drug Alert Number: EL(25)A/14

Date issued: 02 April 2025

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 3 medicines recall notice for: Urospir 50mg/5ml Oral Solution

DMRC reference number: DMRC-35150350

Marketing Authorisation Holder:Rosemont Pharmaceuticals Ltd

Product name: Urospir 50mg/5ml Oral Solution

SNOMED code: 43189611000001104

Active ingredient: Spironolactone

Background

Rosemont Pharmaceuticals Limited is recalling a single batch of Urospir 50mg/5ml Oral Solution (spironolactone) 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.

Approximately 1200 packs have been distributed within the UK market.

Advice for healthcare professionals

Stop supplying the above batch immediately. 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.

• 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.
• This impacts patients that have been prescribed spironolactone oral solution from 29/11/2024 to 31/03/2025.
• 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.

Pharmacists who receive queries from patients should consider checking with the prescriber, where appropriate, to ensure that correct dose has been prescribed.

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).

View full alert here.

Advice for patients

Patients who are taking Urospir 50mg/5ml Oral Solution (spironolactone) should continue to take the medication. Patients concerned about their dose, or are experiencing any of the side effects in Appendix 2 of the download document should contact their GP or pharmacist, who can check the correct dose and can provide advice on side effects.

Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.

Further Information

For all medical information enquiries and information on this product, please contact pharmacovigilance@rosemontpharma.com, or telephone 0113 244 1400. For stock control enquiries please contact customerservices@rosemontpharma.com, or telephone 0113 244 1999.