Class 2 Drug Alert (action within 48 hours) Pfizer Ltd, Counterfeit Lipitor® Tablets 20mg - EL(06)A/17

---

Dear Healthcare Professional,

Lot Number	Expiray Date	Pack Size	First Distributed
067404K3	05 2007	28	Not known

Further to the Drug Alert MDR 30-07/06 that was issued on 19 July 2006, counterfeit packs of a newly identified batch of Lipitor 20mg with a different lot number have been found in the legitimate supply chain. The new lot number, quoted above, was used for genuine Pfizer material distributed until December 2004. Recently supplied tablets bearing lot number 067404K3 are likely to be counterfeit and not legitimately supplied by the manufacturer.

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

The initial results of analysis performed by the MHRA and Pfizer on the counterfeit material indicate that this material is similar to that examined in previous cases and there is no evidence of an immediate risk to patients.

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 download 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