Class 4 Drug Alert (Caution in use): Aurum Pharmaceuticals - Amiodarone Hydrochloride 50 mg/ml concentrate for solution for injection or infusion - EL (09)A/36

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Dear Healthcare Professional,

Batch number	Expiry date	Pack size	First distributed
80593	09/2010	10 ampoules	30/10/2008
80604	12/2010	10 ampoules	17/04/2009

Aurum Pharmaceuticals have informed us that particles have been found in some ampoules of batch 80593 but in addition batch 80604 is being included as a precautionary measure. An investigation is in progress to determine the nature of the particles and the root cause of the problem.

The SPC describes this product as ‘a clear pale yellow solution practically free from particulates’. Provided this product is inspected as per normal parenteral practices any unsuitable ampoules should be detected and discarded.

For medical information enquiries please contact Aurum Pharmaceuticals medical information on 01708 382791.

For enquiries relating to stock returns and credit please contact Aurum Pharmaceuticals customer services on 0800 028 7933.

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 to listed recipients, and relevant clinics and not to GPs and community pharmacists unless known to be relevant.

Yours faithfully

Ian Holloway
DMRC Manager

MHRA Distribution (further recipients by cascade): Distribute to hospitals, wholesalers and relevant clinics