Class 3 Medicines Recall: Urospir 50mg/5ml Oral Solution, EL(25)A/14
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 the SmPC and PIL.
DMRC reference number
DMRC-35150350
Marketing Authorisation Holder
Rosemont Pharmaceuticals Ltd
Medicine Details
Urospir 50mg/5ml Oral Solution
PL: 00427/0251
Active ingredient: Spironolactone
SNOMED code: 43189611000001104
GTIN: 05016119000539
Affected Lot Batch Numbers
| Batch No. | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 1014870 | 30/09/2025 | 150ml | 29/11/2024 |
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).
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 online via the Yellow Card scheme or via the Yellow card app available from the Apple App Store or Google Play Store.
Additional 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.
Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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