Urospir 50mg/5ml Oral Solution
What this means
The MHRA has issued a medicines recall or defect notification. Class 1: risk to life, immediate recall. Class 2: may cause mistreatment or harm, recall within 48 hours. Class 3: unlikely to cause harm, recall within 5 days. Class 4 (defect notification): no recall, caution in use. The medicine remains licensed; only the listed batches are affected. Do not stop treatment without speaking to your doctor or pharmacist.
Class 3 recall · DMRC-35150350
| Product | Licence | Active ingredient | GTIN |
|---|---|---|---|
| Urospir 50mg/5ml Oral Solution | PL: 00427/0251 | Spironolactone | 05016119000539 |
Batches (expiry): 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: