Cytarabine Injection 100mg/ml (1g/10ml) - potential for crystallisation

(Hospira UK Limited) Visually inspect vials for particulate matter prior to use and do not use if crystals are found - Class 4 medicines defect information (EL (13)A/09)

06 March 2013

Class 4 medicines defect information

Caution in use

Distribute to hospital pharmacy level

MDR 03-03/13

Product details

Hospira UK Limited

Cytarabine Injection 100mg/ml (1g/10ml)

PL 04515/0057

Alert details

Batch number Expiry date Pack size First distributed
Z031966AA   March 2014   1 x 10 ml   06 December 2012

Hospira UK Limited has identified the potential for crystallisation in the above batch of Cytarabine Injection 100mg/ml (1g/10ml). The crystals have been determined to be the active ingredient Cytarabine. Hospira UK Limited have identified the most probable cause for crystallisation is from particles of dried Cytarabine introduced during the filling process, which acted as a seed for crystal formation.

The company has informed MHRA that no adverse events have been reported in connection with this crystallisation issue.

Healthcare professionals are asked to visually inspect vials for particulate matter prior to use. If crystals are found the product should not be used.

To obtain replacement stock please contact Hospira UK Limited Customer Services on

For medical information enquiries please contact Hospira UK Limited Medical Information on +44 1926 834400, or email

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 and to general practitioners and community pharmacists for information.

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