Class 2 Medicines Recall: Magnevist and Omniscan Solutions for injection EL (18) A/02
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).
Product information
MDR number
MDR 20-12/17
Company name
Bayer plc
Product description
Magnevist Solution for Injection, 0.5mmol/ml, intravenous
1 x 5ml, 1 x 10ml, 1 x 15ml, 1 x 20ml vial (PL 00010/0542)
5 x 10ml pre-filled syringe (PL 00010/0543)
(Gadopentetate Dimeglumine)
Contact details
Medical information enquiries
For Medical information enquiries, please contact
Bayer UK Medical Information team
Tel: 0118 206 3116
medical.information@bayer.co.uk.
Stock enquiries
For stock enquiries, please contact
Bayer UK Customer Services team
Tel: 0118 206 3999
Company name
GE Healthcare AS
Product description
Omniscan Solution for Injection 0.5 mmol/ml
10 x 5ml, 10 x 10ml, 10 x 15ml, 10 x 20ml vials (PL 00637/0015)
1 x 10ml, 1 x 15ml 1 x 20ml, 10 x 10ml, 10 x 15ml 10 x 20ml pre-filled syringe (PL 00637/0030)
(Gadodiamide)
Contact details
Medical information enquiries
For Medical information, please contact
GE Healthcare Medical Affairs
The Grove Centre, White Lion Road, Buckinghamshire
HP7 9LL
Tel: 01494 544000
Stock enquiries
For stock enquiries, please contact
Stephen McLaughlin, Director of Quality Operations, GE Healthcare Ltd,
IDA Industrial Park, Carrigtwohill, Cork, Ireland
Tel: +353 87 9432162
Brief description of the problem
All unexpired stock of the above products marketed by Bayer plc and GE Healthcare AS is being recalled and should immediately be quarantined. This follows a safety review of the gadolinium containing contrast media by the European Medicines Agency (EMA) which has resulted in the suspension of the above licences as of 01 February 2018.
The review concluded that small amounts of gadolinium are retained in brain tissue after the use of gadolinium contrast agents. More gadolinium retention in the brain has been observed with linear gadolinium agents than with macrocyclic gadolinium agents. Both of the products being recalled are linear agents.
There is currently no evidence that gadolinium deposition in the brain has caused any adverse neurological effects in patients.
Further information can be found on our website.
Please note, Magnevist 2.0mmol/l solution for injection for intra-articular use is outside the scope of this recall.
Supporting information
For Bayer products
Bayer will be writing to all their customers attaching an inventory form for completion and return by 9th February 2018. They will then arrange collection of any quarantined stock and appropriate reimbursement or credit of any quarantined stock.
For GE Healthcare products
For Northern Ireland, stock should be returned to the local distributor (Synapse).
Contact details as follows
Michelle O’Connor
Tel: +353 (0) 1 8624600.
Glenda Hearns
Tel: +353 (0) 1 8624600.
For the rest of the UK, it should be returned to the UK supplier (UPS). Contact details for UPS in the event of a recall:
Ian Evans
Tel: 07890 531246.
Ruth Davies
Tel: 07973 709554
General Quality Inbox
Quality.Department@polarspeed.com.
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Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. NHS regional teams are asked to forward this to relevant clinics, hospitals, mental health trusts, general practitioners and community pharmacists for information.