Class 4 Drug Alert (Caution in use) Mirena 20 Micrograms

Class 4 Drug Alert (Caution in use) Mirena 20 Micrograms

Bayer plc has informed us that they have received two complaints globally concerning Mirena inserters with an insertion tube which is mounted inversely to the handle. This has resulted in inversion of the insertion depth scale, which may lead to incorrect insertion depth and the possibility of a reduced efficacy or adverse events. A very small number of Mirena inserters may potentially be affected by this issue.

Please visit the: MHRA website for more details on this drug alert.

The affected products' details are as follows:

PIP Code Product Description Supplier Affected Batch
2744985 Mirena 20 Micrograms Bayer PLC TU01BPE

This is a caution in use only and therefore we are not accepting stock returns.

For stock return enquiries, please contact Bayer plc by telephone, 01635 563116 or by email to medical.information@bayer.co.uk

Recipients of this Drug Alert should bring it to the attention of relevant contacts.


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.

If you have any questions, then please contact your local Service Centre Customer Services team.