Class 2 Recall - Zoledronic acid SUN 5mg solution for infusion

Sun Pharmaceuticals are recalling the below batches of zoledronic acid due to out of specification results observed for Particulate Matter Test during routine stability testing. This recall is conducted as a precautionary measure as remaining vials may no longer be in line with the licensed product specification with respect to particulate matter.

MHRA drug alert date  11 August 2022

MHRA drug alert link:

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-sun-pharmaceutical-industries-europe-bv-zoledronic-acid-sun-5mg-solution-for-infusion-el-22-a-slash-34?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=7554e8e8-c653-4070-8512-bf893507e32a&utm_content=immediately

Further Information

For more information, medical or supply enquiries, please contact:

Maciej Rosiak (Qualified Person), +31612091885; maciej.rosiak@sunpharma.com  or

Gene Kelleher (Head Quality Europe), +353 86 344 1145; gene.kelleher@sunpharma.com

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.