Clopixol Conc Injection (500mg/ml) - cracked ampoules

(Lundbeck Limited) Reports of cracked ampoules and concerns about guaranteeing sterility – class 2 actions within 48 hours (EL (11)A/33)

Class 2 medicines recall

Action Within 48 Hours

Pharmacy-level recall

MDR 68-12/11

Product details

Lundbeck Limited

Clopixol Conc Injection (500mg/ml)

(zuclopenthixol decanoate 500mg/ml injection)

PL 00458/0060

  • Batch number: 2277494
    • Expiry date: April 2015
    • Pack size: 5 x 1ml
    • First distributed: 4 August 2011
  • Batch number: 2281683
    • Expiry date: April 2015
    • Pack size: 5 x 1ml
    • First distributed: 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.

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)

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Published 17 December 2014