Javelin .....
Defective Medicines Report Centre
Market Towers
1 Nine Elms Lane
London
SW8 5NQ
Telephone: +44 (0)20 7084 2574 Fax: +44 (0)20 7084 2676
MHRA Distribution:
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)
Page 1 of 3
D R U G A L E R T
CLASS 2 MEDICINES RECALL
Action within 48 hours
Hospital, wholesaler and clinic level recall
Date: 21 May 2010 EL (10)A/11 Our Ref: MDR 41-05/10
_________________________________________________________________________
Dear Healthcare Professional,
Therabel Pharma UK Ltd
Dyloject Vials 75mg/2ml
Diclofenac sodium
PL 25053/0001
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.
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.
Page 2 of 3
Date: 21 May 2010 EL (10)A/11 Our Ref: MDR 41-05/10
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
Page 3 of 3
Date: 21 May 2010 EL (10)A/11 Our Ref: MDR 41-05/10
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.
