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

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