Class 4 Medicines Defect Information: Ennogen Healthcare Limited, Zoledronic Acid Ennogen 4mg/5ml Concentrate For Solution For Infusion, El (24)a/53

Ennogen Healthcare Limited is recalling Zoledronic Acid Ennogen 4mg/5ml concentrate for solution for infusion in the United Kingdom because Patient Reminder Cards were not included with the medication as required. Patient Reminder Cards are safety materials designed to inform patients about important risks and precautions related to this medicine.

Recalling firm

Ennogen Healthcare Limited

Reason

Ennogen Healthcare Limited has identified that action had not been taken to ensure the Patient Reminder Card (PRC) was distributed alongside the packs of product as part of the approved Additional Risk Minimisation Measures (RMM).

Classification

Class III

Category

drug recall

Country

United Kingdom

Agency

UK Medicines and Healthcare products Regulatory Agency

Recall date

2024-11-07

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/7b96c968-6f9a-4732-b372-d545db7f35b2