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Class 2 Drug Alert (Action within 48 hours): AstraZeneca UK Ltd - Citanest 1% solution for injection, multi-dose vials 10mg/ml, prilocaine hydrochloride - EL (10)A/03

Document details:

Type: Drug Alert
Series No: EL (10)A/03
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 2
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.

DRUG ALERT

CLASS 2 MEDICINES RECALL
Action within 48 hours
For distribution to hospitals, wholesalers and relevant clinics
15 February 2010 EL (10)A/03 Our ref:  MDR 20-02/10

Dear Healthcare Professional,

AstraZeneca UK Ltd

Citanest 1% solution for injection multi-dose vials 10mg/ml

Prilocaine Hydrochloride

PL 17901/0118

AstraZeneca UK Ltd is recalling all remaining stock of batches of the above product expiring before the end of 2011. This action is being taken because routine stability testing has indicated that the preservative levels may become too low after 24 months from manufacture.

A list of the batches to be recalled is included below.

For medical information enquiries please contact AstraZeneca UK medical information on 0800 783 0033. Any affected batches should be returned via its agents - AAH Pharmaceuticals or Alliance Healthcare where credit will be issued. For any further stock enquiries please contact AstraZeneca UK Supply Chain Team on 0800 032 0501.

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 all this document to relevant clinics, GPs and community pharmacists.

Yours faithfully

Ian Holloway
DMRC Manager

Recall

List of 12 batches of Citanest 1% Solution for injection Multi-dose vials 10mg/ml to be recalled

Batch number Expiry date  Pack size  First distributed
FX337 2/12/2011 1X50ML  March 2009
FS216 30/6/2011 1X50ML   January 2009
FP186 29/5/2011 1X50ML  December 2008
FM069 19/5/2011 1X50ML  October 2008
FJ545 26/3/2011 1X50ML  August 2008
FF738 14/12/2010 1X50ML  May 2008
FD238 11/12/2010 1X50ML  March 2008
FA944 5/9/2010 1X50ML  January 2008
EY517 28/8/2010 1X50ML  November 2007
EX030 25/7/2010 1X50ML  October 2007
EV669 2/5/2010 1X50ML  October 2007
EV050  2/5/2010 1X50ML  August 2007


Don't recall

Citanest 1% batches exempt from this recall.
Please note that batches expiring after the end of 2011 are not being recalled at present. The following four batches have been distributed and should remain in use. A recall decision will be made at a later stage.

 Batch number  Expiry date
 GH649  29/1/2012
 GF166  29/1/2012
 GD866  29/1/2012
 GB188  5/3/2012

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)
Page last modified: 15 February 2010