Class 2 Drug Alert (Action within 48 hours): LEO Laboratories Limited - Sodium Fusidate 500 mg for Intravenous Infusion - EL (10)A/18

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Dear Healthcare Professional,

Batch Number	Expiry Date	Pack Size	First Distributed
DC1313	14 Sep 2010	1 vial active + diluent	16 Jan 2008
DC3392	14 Nov 2010	1 vial active + diluent	17 Mar 2008
DC4466	14 Feb 2011	1 vial active + diluent	27 May 2008
DC8315	14 May 2011	1 vial active + diluent	08 Sep 2008
DC9814	14 May 2011	1 vial active + diluent	16 Dec 2008
DD1440	15 Sep 2011	1 vial active + diluent	21 Jan 2009
DD4563	14 Jan 2012	1 vial active + diluent	28 Apr 2009
DD5430	14 Jan 2012	1 vial active + diluent	28 Jul 2009
DD9538	14 May 2012	1 vial active + diluent	26 Oct 2009
DE2191	14 Sep 2012	1 vial active + diluent	23 Mar 2010
DE2192	14 Sep 2012	1 vial active + diluent	25 May 2010

LEO Laboratories Limited is recalling all remaining stock of the above batches. This is because glass particles have been identified in a very small number of vials of active material. The particles observed to date have been too large to pass through any needle which may be used for administration of this product. There is a potential risk of smaller particles being present in the product, however, so the above batches are being recalled as a precautionary measure. No technical complaints related to this issue have been received in the UK.

The root cause of this issue has already been identified, and corrective measures have been put in place.

The company is expecting new stock to be available towards the end of next week (ie week commencing 19 July). If, in the meantime, this medication is considered essential for certain patients please contact Medical Information at LEO Laboratories Limited on 01844 347333 for advice.

Pharmacists are asked to quarantine remaining stocks of these batches and return them to the original wholesaler for credit. For further stock return enquiries, please contact Movianto on 01234 248500.

For medical information enquiries, please contact LEO Laboratories Limited on 01844 347333.

Recipients of this Drug Alert are requested to bring it to the attention of relevant professionals by copy of this letter.

Yours faithfully

Alison Bunce
Pharmaceutical Assessor, DMRC

MHRA Distribution (further recipients by cascade):

Regional contacts for NHS trusts and provider units
Chief pharmacists: England, Scotland, Wales, Northern Ireland
Prison Health Policy Unit (DH)
Chief pharmacists: Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special hospitals
Healthcare Commission for distribution to independent health care establishments
Primary care trusts (England)