Class 3 recall-Urospir 50mg/5ml solution

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.

MHRA drug alert link https://www.gov.uk/drug-device-alerts/class-3-medicines-recall-urospir-50mg-slash-5ml-oral-solution-el-25-a-slash-14?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=9691ad0b-c6c7-495b-b16f-dd6e46fd62a0&utm_content=immediately

MHRA ref: DMRC-35150350

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.

Please return all affected stock to your original supplier for credit. Unfortunately we can only accept stock purchased from us (Alliance Healthcare Distribution Limited). Any other stock will be returned to your stores/Pharmacies.

Please note that anything not returned to us, or notified to us, within 3 months of this notification, cannot be reimbursed by way of a credit.