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Teva UK Ltd
Epirubicin Hydrochloride 2 mg/ml
Solution for injection or infusion in vials
PL 00289/1162
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. |
