Class 2 Drug Alert (Action within 48 hours): Therabel Pharma UK Ltd - Dyloject Vials 75 mg/2 ml - EL (10)A/11

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Dear Healthcare Professional,

Product in Javelin Pharmaceuticals UK and Therabel Pharma UK Liveries

Therabel Pharma UK Ltd are recalling all remaining stock of batches listed in Appendix 1 (below). The majority of batches are in Javelin Pharmaceuticals UK livery but one batch is in Therabel Pharma UK livery.

These batches may be contaminated with small amounts of white particles. The particles are not readily visible and work is ongoing to determine the nature, size and risk posed by this contamination. In order to minimise risk to patients, all remaining stock is being recalled.

A review of pharmacovigilance information, carried out by the marketing authorisation holder, does not appear to indicate any detected safety concerns and these batches have been in use since 2008. However, as the contamination is not readily visible it could be missed during normal checks prior to administration.

We understand this product is mainly used in a hospital environment and recipients are asked to check ward and clinic stocks and withdraw any of the listed batches.

Stock should be returned via the original wholesaler for credit. For stock return and general enquiries please call Therabel Pharma UK Ltd on 01223 257759.

For medical information enquiries please call Therabel Pharma UK Ltd Medical Information on 0800 066 5446.

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 relevant clinics.

Yours faithfully

Ian Holloway
DMRC Manager

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Appendix 1: Dyloject Vials 75mg/2ml for recall – all packs 10 x 2 ml vials

Batch	Livery	Date of manufacture	Expiry date	Date first distributed
D7004	Javelin	12/2007	05/2010	14/08/2008
D7005	Javelin	12/2007	05/2010	27/10/2008
D8001	Javelin	02/2008	07/2010	13/02/2009
D8003	Javelin	02/2008	07/2010	12/12/2008
D8006	Javelin	04/2008	09/2010	02/04/2009
D8007	Javelin	04/2008	09/2010	15/06/2009
D8008	Javelin	04/2008	09/2010	12/05/2009
D8009	Javelin	04/2008	09/2010	15/07/2009
D8010	Javelin	04/2008	09/2010	20/10/2008
D8011	Javelin	05/2008	10/2010	19/08/2009
D8012	Javelin	05/2008	10/2010	21/09/2009
D8014	Javelin	07/2008	12/2010	16/11/2009
D8015	Javelin	07/2008	12/2010	19/10/2009
D8016	Javelin	08/2008	01/2011	08/12/2009
D8018	Javelin	08/2008	01/2011	12/01/2010
D8019	Javelin	08/2008	01/2011	09/02/2010
D8020	Javelin	09/2008	02/2011	04/03/2010
D8021	Javelin	09/2008	02/2011	29/03/2010
D8022	Javelin	09/2008	02/2011	26/04/2010
089001	Therabel	09/2009	02/2012	28/04/2010

Additional information
The single Therabel batch number is an all-numeric format.

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)