Class 2

Class 2 Medicines Recall: Sun Pharmaceutical Industries Europe BV, Zoledronic acid SUN 5mg solution for infusion, EL(22)A/34

MDR Number: MDR 054-08/22

Company name: Sun Pharmaceutical Industries Europe BV

Product description: Zolendronic acid SUN 5mg solution for infusion PL31750/0054

Details of the affected batch:

Batch number

Expiry date

Pack size

First Distributed

JKX5541B

11/2022

1x100ml vial

15-Jul-2021

HAC1087A

05/2023

1x100ml vial

15-Oct-2021

HAC3395A

08/2023

1x100ml vial

18-Mar-2022

HAD0156B

01/2024

1x100ml vial

17-May-2022

Active Pharmaceutical Ingredient: zoledronic acid (as monohydrate)

Brief description of problem:

Sun Pharmaceuticals are recalling the above 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.

Advice to Healthcare Professionals:

Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

If patients felt unwell after the administration of the affected batches above, please report this to the Marketing Authorisation Holder and complete a Yellow Card report via the MHRA Yellow Card scheme.

Advice to Patients:

  • Patients are not required to take any action at this time. This product is administered by healthcare professionals only. If you have concerns about zoledronic acid that has been given to you, please contact your healthcare professional.
  • The Marketing Authorisation Holder has not received any reports of adverse reactions related to the issue above, however, patients who experience any adverse reactions should seek medical attention. These should also be reported via the MHRA Yellow Card scheme.

Company contacts for 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.

To access the full recall:

Class 2 Medicines Recall: Sun Pharmaceutical Industries Europe BV, Zoledronic acid SUN 5mg solution for infusion, EL(22)A/34