MHRA Recall of Gadolinium-containing contrast agents

MHRA Recall of Gadolinium-containing contrast agents

Gadolinium-containing contrast agents: removal of Omniscan and iv Magnevist, restrictions to the use of other linear agents

A class 2 medicine recall – action within 48 hours – has now been issued by the MHRA for Magnevist (Bayer plc) and Omniscan Solution (GE Healthcare).

Bayer plc and GE Healthcare AS are recalling batches of Magnevist Solution for injection, 0.5mmol/ml, intravenous and Omniscan Solutions for injection 0.5 mmol/ml following a safety review of the gadolinium containing contrast media by the European Medicines Agency (EMA).  The MHRA has indicated that all unexpired stock of the above products marketed by Bayer plc and GE Healthcare AS is being recalled and should immediately be quarantined. Note that Magnevist 2.0mmol/l solution for injection for intra-articular use is outside the scope of this recall.

For further information: https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-magnevist-and-omniscan-solutions-for-injection-el-18-a-02

Chief Investigators of any affected Edinburgh University/NHS Lothian Sponsored studies should ensure that their research teams comply with this MHRA recall notice.