Class 3 Medicines Recall: Urospir 50mg/5ml Oral Solution, El(25)a/14
Urospir 50mg/5ml Oral Solution Recall Summary Rosemont Pharmaceuticals is recalling one batch of Urospir 50mg/5ml Oral Solution (a water pill medication) in the United Kingdom because the dosing instructions printed in the documentation contain calculation errors. The affected batch has incorrect information about how many millilitres patients should take, which could lead to dosing mistakes. This recall applies to patients in the UK who received this specific batch.
- Recalling firm
- Urospir 50mg/5ml Oral Solution
- Reason
- 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.
- Classification
- Class II
- Category
- drug recall
- Country
- United Kingdom
- Agency
- UK Medicines and Healthcare products Regulatory Agency
- Recall date
- 2025-04-02
- Status
- Ongoing
- Distribution
- United Kingdom
Official recall notice from UK Medicines and Healthcare products Regulatory Agency
Recall details on Nibble Recalls: https://trynibble.app/recalls/de647719-29e1-436d-a6b9-46277354a2dd