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Novartis Vaccines has informed the MHRA about a potential problem with the packaging of syringes supplied with the following batches of Rabipur® inactivated rabies vaccine:
Batch Number |
Expiry Date |
Pack Size |
First Distributed |
490011C |
30 Apr 2015 |
1 Dose |
12 Oct 2011 |
493011A |
31 May 2015 |
1 Dose |
22 Dec 2011 |
The outer packaging of some of the individually packed syringes associated with a different batch of Rabipur®, but which used the same syringe batch, was found to be discoloured and there was mould present in some cases. No samples from the above listed batches have been found to be affected.
The risk of any syringes provided with batches 490011C and 493011A being affected is considered by the company to be very low. As a precaution, however, healthcare professionals are requested to inspect the outer packaging of these syringes for signs of a yellow discolouration or mould. If no issues are identified by the inspection, the syringes may be used as normal. If discolouration or mould is identified, the affected syringes should be discarded and replaced with commercially available syringes with the same specification, ie a 2ml luer cone with 0.6x30mm needle. If this needle is not available, the product can be injected using a needle of a size to suit the patient.
A new batch of unaffected Rabipur® is expected to be available for distribution during week commencing 09 April 2012.
If you have any questions regarding this information, please contact Novartis Vaccines Customer Services on 08457 451500.
(Via MHRA Drug Alert - accessed 21/03/12)