Bravelle 75IU powder for solution for injection - Ferring Pharmaceuticals Limited (CLDA (15)A/08) - 22 October 2015
Ferring Pharmaceuticals Limited is recalling all batches of Bravelle 75IU powder for solution for injection on the UK market.
Product information
CLDA number
CLDA (15)A/08
MDR number
43-10/15
Company name
Ferring Pharmaceuticals Limited
Product description
Bravelle 75IU powder for solution for injection - PL 03194/0087
Batch number/ expiry
All batches
Brief description of problem
During routine testing of a small number of batches specific to the USA and Canada, reduced potency was identified after storage for 12 months (the shelf-life is 24 months). No European batches have been found to be affected; however Ferring is recalling all batches on the UK market as a precautionary measure.
Ferring has informed us that one batch with a longer expiry date can be made available for those patients who are already on treatment and for whom the clinician wishes to complete a cycle without interruption. Please contact Ferring Customer Services to arrange this, see details below.
Company contact for medical information and stock enquiries
Ferring Customer Services
Telephone: 0844 931 0052
Email: customer.services@ferring.com
Company contact for medical information enquiries
Ferring Medical Information
Email: medical.uk@ferring.com