Class 2 Drug Alert (Action within 48 hours): Teva UK Ltd - Epirubicin Hydrochloride 2 mg/ml solution for injection or infusion in vials - EL (10)A/05

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Dear Healthcare Professional,

Pack size	Batch number	Expiry date	First distributed
5ml	09D09PB	30 April 2011	May 2009
5ml	09D09PJ	30 April 2011	Dec 2009
25ml	09D20LA	30 April 2011	May 2009
25ml	09G29PA	31 July 2011	Jan 2010

Teva UK Ltd are recalling all remaining stock of the above batches due to errors in both the SPC and PIL. Dilution tables in both documents are correct and result in concentrations between 0.6 and 1.6 mg/ml. However, concentrations quoted in the text are wrongly cited as 0.6 to 2.6 mg/ml. The error is present at three locations in the PIL and one in the SPC.

We understand that replacement stock with correct information present will not be available from Teva for about two months. As far as we can establish, suitable alternatives are marketed and should be available from wholesalers.

For medical information enquiries please contact Teva UK Ltd on 020 7540 7117.

Remaining stocks of the above batches should be returned to the original wholesaler for credit. For further stock enquiries please contact Teva UK Customer Liaison Team on 0800 590502.

Recipients of this Drug Alert are requested to bring it to the attention of relevant professionals by copy of this letter. Primary care trusts are asked to forward this document to hospitals and relevant clinics.

Yours faithfully

Ian Holloway
DMRC Manager

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)