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Thursday, 12 January 2012

Lundbeck Limited - Clopixol Conc Injection - recall cracked ampules - FIDDAMAN blog

Dear Healthcare Professional,

Lundbeck Limited

Clopixol Conc Injection (500mg/ml)

(zuclopenthixol decanoate 500mg/ml injection)

PL 00458/0060

Batch number Expiry date Pack size First distributed

2277494 April 2015 5 x 1ml 4 August 2011

2281683 April 2015 5 x 1ml 20 September 2011

Lundbeck Limited has just informed us that they are recalling the above batches. This is because there have been a small number of reports of cracked ampoules associated with the bulk batch from which these batches are packed and there are concerns that sterility assurance cannot be guaranteed.

All remaining stock of these batches should be quarantined and returned to Alliance Healthcare for credit. We understand that there is sufficient stock from other batches available to replenish recalled stock. For enquiries relating to stock return please call Alliance Healthcare.

For medical information enquiries, please call 07785 293179 over the Christmas period. From 3 January 2012 please contact 01908 638972

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Primary care trusts are asked to forward this to relevant clinics, general practitioners and community pharmacist.

Yours faithfully

Alison Bunce

Pharmaceutical Assessor, DMRC

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)

Download documents:

Class 2 Drug Alert (Action within 48 hours): Lundbeck Limited - Clopixol Conc Injection (500mg/ml) - EL (11)A/33 (161Kb)

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