Class 4 Medicines Defect Information: Recordati Rare Diseases, Pedea 5 mg/ml solution for injection

Recordati Rare Diseases T/A Recordati Rare Diseases UK Ltd has made the MHRA aware that specific batches of Pedea 5 mg/ml solution for injection have been packaged with the incorrect Product Information Leaflet (PIL).

MHRA drug alert date: 25th October 2022

MHRA drug alert link: 

https://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-recordati-rare-diseases-pedea-5-mg-slash-ml-solution-for-injection-el-22-a-slash-45?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=8880eab9-9fb3-431a-85f0-7f29ba803bf5&utm_content=immediately

This is a caution in use only we are not accepting stock returns - if any defective stock is found it should be returned directly to the manufacturer.

For further information, including medical enquiries and stock information, please contact:

Recordati Rare Diseases UK Ltd (local representative, WDA(H): 15720) on Tel: +44 (0)1491 414333 or +33 1 47 73 64 58 or email: RRDmedinfo@recordati.com

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 hospital pharmacists and pediatric doctors and nurses working in hospital setting for information.