Class 2 Recall on Esmya Tab 5mg

Recalls and Alerts

Class 2 Recall

Class 2 Recall on Esmya Tab 5mg

Gedeon Richter (UK) Ltd is recalling all unexpired stock of the above products from patients, pharmacies and wholesalers following a new case of liver failure requiring liver transplant in a patient taking the medicine. To protect patients while a safety review is conducted, the European Medicines Agency's safety committee, Pharmacovigilance Risk Assessment Committee, (PRAC) has recommended that women stop taking 5mg ulipristal acetate (Esmya and generic medicines) for uterine fibroids.

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
3707510	ESMYA TAB 5MG	GEDEON RICHTER LTD	ALL STOCK

For stock control and/or medical information enquiries please contact Gedeon Richter (UK) Ltd on +44 (0) 1279 406 759

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

Please note that Alliance Healthcare do not stock and we are not accepting stock returns.

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