30 Oct 2012
Class 2 Medicines Recall – Action Within 48 hours – clinic, pharmacy and wholesaler level recall
Ref: EL(12)A/34
Agrippal (influenza vaccine) suspension for injection in pre-filled syringe
(Manufactured by Novartis Vaccines and Diagnostics)
PL 13767/0004
| Batch number |
Expiry date |
Pack size |
First distributed |
| 126201A |
31 May 2013 |
10 x pre-filled syringes |
9 October 2012 |
| 126201 |
31 May 2013 |
10 x pre-filled syringes |
17 October 2012 |
A precautionary recall of the above batches of Agrippal (influenza vaccine) suspension for injection in pre-filled syringes has been issued by the Medicines and Healthcare products Regulatory Agency (MHRA) and Novartis Vaccines and Diagnostics.
During additional testing visible protein aggregates were found in one of the components of the vaccine. This was identified during the course of an investigation. Protein aggregation can occur in influenza vaccines and consists mostly of viral proteins expected in the vaccine. Protein aggregation when observed is transient and disappears upon shaking.
At the time of releasing the affected batches of Agrippal onto the UK market no visible protein aggregates were detected.
There is no evidence of any new safety concerns or any impact on efficacy.
No adverse reactions have been reported.
Patients who already have had an affected batch should have no cause for concern and there is no need for revaccination.
Pharmacists need to quarantine any remaining stock of affected batches and return to the original supplier for credit.
For stock return queries, contact Novartis Vaccines customer services on 08457 451 500.
For medical information queries, contact Novartis Vaccines medical information on 01748 828 816.
