Class 2 Drug Alert (Action Within 48 hours): Novartis Vaccines and Diagnostics S.r.l. - Agrippal suspension for injection in pre-filled syringe - Influenza Vaccine - EL (12)A/34

At the request of MHRA, Novartis Vaccines and Diagnostics S.r.l. is executing a precautionary recall of the above batches. This is due to the presence, in one of the components, of visible protein aggregates that were identified following additional testing during the course of an investigation. Such protein aggregation can occur in influenza vaccines. The aggregation consists mostly of viral proteins expected in the vaccine, and when observed, aggregation is transient and disappears upon shaking as recommended in product labelling. No visible protein aggregates were detected at the time of product release in any of these UK batches.

Based on the information available, there is no evidence of any new safety concerns or of any impact on efficacy. No adverse reactions which may be associated with this issue have been reported to Novartis in connection with these batches. Those who have had a flu vaccine from these batches should have no cause for concern and there is no need for revaccination.

Remaining stocks of the affected batches should be quarantined and returned to the original supplier for credit. For enquiries relating to stock returns please contact Novartis Vaccines Customer Services on 08457 451 500

For medical information enquiries, please telephone Novartis Vaccines Medical Information on 01748 828 816

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)