Class 2 medicines recall (action within 48 hours): Pfizer Ltd, Lipitor® 20mg Tablets, EL(06)A/16

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Dear Healthcare Professional,

Lot Number	Expiry Date	Pack Size	First Distributed
004405K1	11 2007	28	Not known

Drug Alert MDR 23-07/05 issued in July 2005 recalled, with the assistance of Pfizer, all remaining stock of the above lot due to the discovery of counterfeit packs in the legitimate supply chain. No further distribution of the above lot number of Lipitor 20mg should have taken place since July 2005. The MHRA has learnt that further counterfeit material of the above lot number has been supplied through the legitimate supply chain in 2006 and this is addressed in this notification. This material has not been legitimately supplied by the manufacturer.

The initial results of analysis performed by the MHRA on the counterfeit material indicate that this material is similar to that examined in the previous case in July 2005 and is not likely to pose an immediate risk to patients.

The MHRA, with assistance offered by Pfizer Ltd, is recalling any remaining stock of the above lot of  Lipitor. No other lots are affected.

To make arrangements to return any stock from this lot only please contact the Customer Services department of  Pfizer Ltd on 01304 646600.

For questions of a medical nature please contact Pfizer Medical Information on 01304 616161

Pfizer have confirmed that there should be adequate stocks of Lipitor 20mg available to supply against new orders.

Recipients of this Drug Alert should bring this information to the attention of relevant contacts by copy of this letter. Primary Care Trusts are asked to bring this information to the attention of General Practitioners and Community Pharmacists, by copy of this letter

Yours faithfully,

Ian Holloway
DMRC Manager

Two further advice sheets are attached with the document below

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)
Medical Supplies Agency (MOD)
Chief Pharmacists:  Jersey, Guernsey, Alderney, Sark, Isle of Man, Gibraltar
Special Hospitals
Healthcare Commission for distribution to Independent Health Care Establishments