Class 4 Drug Alert (caution in use): Focus Pharmaceuticals Limited - Fluconazole 2mg/ml Solution for Infusion – EL (09)A/27

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Dear Healthcare Professional,

Batch number	Expiry date	Pack size	First distributed
0802849	08/2013	25ml	01/12/2008
0802740	08/2013	100ml	01/12/2008
0802760	08/2013	100ml	24/09/2009
0802773	08/2013	100ml	24/09/2009
0802818	08/2013	100ml	02/10/2009
0802834	08/2013	100ml	02/10/2009

Focus Pharmaceuticals Limited has informed the MHRA that there is an error in the patient information leaflet (PIL) supplied in the above batches of Fluconazole 2mg/ml Solution for Infusion, concerning the dose to be administered to children for the indication mucosal candidiasis. The leaflet text reads:

Treatment of mucosal candidiasis - the usual dose is 3-12mg/kg per day. 6mg/kg may be given on day 1.

The text should read:

Treatment of mucosal candidiasis – the usual dose is 3mg/kg per day. 6mg/kg may be given on day 1.

The remaining text of the leaflet is correct, as is the labelling of the product and the SPC.

Due to current product shortages, these batches are not being recalled. Focus Pharmaceuticals Limited has confirmed that no further batches containing the incorrect PIL will enter the market.

Further information

For further enquiries, please telephone Focus Pharmaceuticals Limited on 01283 495280.

Recipients of this Drug Alert are requested to bring this 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)