Class 2 Drug Alert (Action Required Within 48 Hours): Novartis Vaccines and Diagnostics S.r.l. - Agrippal suspension for injection in pre-filled syringe - Influenza Vaccine - EL (12) A/34
Novartis Vaccines and Diagnostics S.r.l.
Agrippal suspension for injection in pre-filled syringe(Influenza Vaccine)PL 13767/0004
Summary:
At the request of MHRA, Novartis Vaccines and Diagnostics S.r.l. is executing a precautionary recall of Agrippal suspension for injection in pre-filled syringes. 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.
Batch Number
|
Expiry Date
|
Pack Size
|
First Distributed
|
126201A
|
31 May 2013
|
10 x pre-filled syringes
|
9 Oct 2012
|
126102
|
31 May 2013
|
10 x pre-filled syringes
|
17 Oct 2012
|
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.
