21 March 2012

Rabipur rabies vaccine alert – caution in use

Novartis Vaccines has informed the Medicine and Healthcare products Regulatory Agency (MHRA) of a potential issue relating to the outer packaging of some of the syringes supplied with two batches of Rabipur rabies vaccine [1].

The presence of yellow discolouration and mould was detected on the syringe packaging supplied with two batches of Rabipur vaccine. The same syringes were supplied with two batches of vaccine distributed in the United Kingdom. The potentially affected batches are:

Batch number	Expiry date	Pack size	First distributed
490011C	30 April 2015	1 dose	12 October 2011
493011A	31 May 2015	1 dose	22 December 2011

 

The risk of the syringes being damaged is very low, and the vaccine and diluents have not been affected.

Health professionals are advised to inspect the packaging of the above batches of Rabipur vaccine for evidence of yellow discolouration or mould.  If no discolouration or mould is detected the syringes may be used as normal. If discolouration or mould is detected, the syringes should be discarded and replaced with commercially available syringes and needles of the same specification. If the same size needle is not available the vaccine can be administered using a needle size to suit the patient.  

If you have any questions regarding this information, please contact Novartis Vaccines Customer Services on 08457 451500.

A new batch of unaffected Rabipur vaccine is expected to be available for distribution during the week of 9 April 2012.

Medical information enquiries should be directed to Novartis Vaccines on 01748 828816

Reference

1. Medicines and Healthcare products Regulatory Agency. Class 4 drug alert: Novartis Vaccines and Diagnostics GmbH – Rabipur – EL(12)A/13. 21 march 2012. [Accessed 21 March 2012] Available at: http://www.mhra.gov.uk/Publications/Safetywarnings/Drug

Alerts/CON146767