Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.
DRUG ALERT
CLASS 2 MEDICINES RECALLPHARMACY OR EQUIVALENT LEVEL RECALL
| 29 September 2009 | EL (09)A/26 | Our ref: MDR 71-09/09 |
Dear Healthcare Professional,
GlaxoSmithKline Biologicals sa
Cervarix suspension for injection in prefilled syringes
Human papillomavirus vaccine
| Batch number | Expiry date | Pack size | First distributed |
| AHPVA043BB | 09/2010 | 1 Syringe + needle | 1 May 2009 |
Following the tragic death of a young girl, who had received vaccination from the above batch of Cervarix, the Department of Health has issued a quarantine notification.
As a further precautionary measure, GlaxoSmithKline Biologicals sa is now undertaking a voluntary recall of the above batch of Cervarix pending further investigation.
Please quarantine any remaining stocks of this batch. Movianto UK Ltd will contact customers directly regarding stock and the details of the product to be collected. Movianto can be contacted by email (customercare.uk@movianto.co.uk)
The benefit risk assessment for the vaccine remains unchanged; there is currently no proven link between vaccination and the event and the HPV vaccination programme will continue.
No other batches are affected by this recall. Further stocks of vaccine from different batches can be ordered in the usual way.
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 distribution centres and immunisation teams.
|
Information for consumers
|
|||||
|---|---|---|---|---|---|
|
In the UK more than 1.4 million doses of the HPV vaccine have now been administered since the vaccination programme started last year (September 2008). The benefit risk profile of Cervarix remains positive; ie the benefits outweigh the risks. The majority of the side effects that have been reported to the MHRA via the Yellow Card Scheme are mild (not serious). What should I do if I have received a dose of vaccine from this batch recently? Please be assured that there remains no proof of any specific problem with the recalled batch. The recall remains purely precautionary at this point. However, if you do feel unwell, or suspect that you are experiencing a side effect from the vaccine, then you should seek medical attention from your doctor or healthcare professional. If you suspect that you have suffered from a suspected side effect, then please report it to the MHRA via the Yellow Card Scheme at www.yellowcard.gov.uk (external link) What should I do if my daughter is due to receive the vaccine? If parents or young people are worried about the safety of any vaccine they should speak to their GP to discuss their concerns, or visit http://www.nhs.uk/ (external link) where they can find more information about all vaccinations routinely given to children and young people. |
Yours faithfully
Alison Bunce
Pharmaceutical Assessor, DMRC
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 healthcare establishments
Primary care trusts (England)
Class 2 Drug Alert (Action within 48 hours): GlaxoSmithKline UK - Cervarix suspension for injection in pre-filled syringes – EL (09)A/26 
